Patient Selectable Joint Arthroplasty Devices and Surgical Tools

ABSTRACT

Disclosed herein are tools for repairing articular surfaces repair materials and for repairing an articular surface. The surgical tools are designed to be customizable or highly selectable by patient to increase the speed, accuracy and simplicity of performing total or partial arthroplasty.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority from U.S. Provisional Application Ser.No. 61/034,048, filed Mar. 5, 2008, entitled “Patient Selectable JointArthroplasty Devices and Surgical Tools,” and U.S. ProvisionalApplication Ser. No. 61/052,430, filed May 12, 2008, entitled “PatientSelectable Joint Arthroplasty Devices and Surgical Tools.”

This application is also a continuation in part of U.S. Ser. No.11/671,745, filed Feb. 6, 2007, entitled “Patient Selectable JointArthroplasty Devices and Surgical Tools”, which in turn claims thebenefit of U.S. Ser. No. 60/765,592 entitled “SURGICAL TOOLS FORPERFORMING JOINT ARTHROPLASTY” filed Feb. 6, 2006; U.S. Ser. No.60/785,168, entitled “SURGICAL TOOLS FOR PERFORMING JOINT ARTHROPLASTY”filed Mar. 23, 2006; and U.S. Ser. No. 60/788,339, entitled “SURGICALTOOLS FOR PERFORMING JOINT ARTHROPLASTY” filed Mar. 31, 2006.

U.S. Ser. No. 11/671,745 is also a continuation-in-part of U.S. Ser. No.11/002,573 for “SURGICAL TOOLS FACILITATING INCREASED ACCURACY, SPEEDAND SIMPLICITY IN PERFORMING JOINT ARTHROPLASTY” filed Dec. 2, 2004which is a continuation-in-part of U.S. Ser. No. 10/724,010 for “PATIENTSELECTABLE JOINT ARTHROPLASTY DEVICES AND SURGICAL TOOLS FACILITATINGINCREASED ACCURACY, SPEED AND SIMPLICITY IN PERFORMING TOTAL AND PARTIALJOINT ARTHROPLASTY” filed Nov. 25, 2003 which is a continuation-in-partof U.S. Ser. No. 10/305,652 entitled “METHODS AND COMPOSITIONS FORARTICULAR REPAIR,” filed Nov. 27, 2002, which is a continuation-in-partof U.S. Ser. No. 10/160,667, filed May 28, 2002, which in turn claimsthe benefit of U.S. Ser. No. 60/293,488 entitled “METHODS TO IMPROVECARTILAGE REPAIR SYSTEMS”, filed May 25, 2001, U.S. Ser. No. 60/363,527,entitled “NOVEL DEVICES FOR CARTILAGE REPAIR, filed Mar. 12, 2002 andU.S. Ser. Nos. 60/380,695 and 60/380,692, entitled “METHODS ANDCOMPOSITIONS FOR CARTILAGE REPAIR,” and “METHODS FOR JOINT REPAIR,”filed May 14, 2002.

U.S. Ser. No. 11/671,745 is also a continuation-in-part of U.S. Ser. No.10/728,731, entitled “FUSION OF MULTIPLE IMAGING PLANES FOR ISOTROPICIMAGING IN MRI AND QUANTITATIVE IMAGE ANALYSIS USING ISOTROPIC ORNEAR-ISOTROPIC IMAGING,” filed Dec. 4, 2003, which claims the benefit ofU.S. Ser. No. 60/431,176, entitled “FUSION OF MULTIPLE IMAGING PLANESFOR ISOTROPIC IMAGING IN MRI AND QUANTITATIVE IMAGE ANALYSIS USINGISOTROPIC OR NEAR ISOTROPIC IMAGING,” filed Dec. 4, 2002.

U.S. Ser. No. 11/671,745 is also a continuation-in-part of U.S. Ser. No.10/681,750, entitled “Minimally Invasive Joint Implant with3-Dimensional Geometry Matching the Articular Surfaces,” filed Oct. 7,2003, which claims the benefit of U.S. Ser. No. 60/467,686, entitled“Joint Implants,” filed May 2, 2003 and U.S. Ser. No. 60/416,601,entitled Minimally Invasive Joint Implant with 3-Dimensional GeometryMatching the Articular Surfaces,” filed Oct. 7, 2002.

Each of the above-described applications is hereby incorporated byreference in their entirety.

FIELD OF THE INVENTION

The present invention relates to orthopedic methods, systems andprosthetic devices and more particularly relates to surgical templatesdesigned to achieve optimal cut planes in a joint in preparation forinstallation of a joint implant.

BACKGROUND OF THE INVENTION

There are various types of cartilage, e.g., hyaline cartilage andfibrocartilage. Hyaline cartilage is found at the articular surfaces ofbones, e.g., in the joints, and is responsible for providing the smoothgliding motion characteristic of moveable joints. Articular cartilage isfirmly attached to the underlying bones and measures typically less than5 mm in thickness in human joints, with considerable variation dependingon joint and site within the joint. In addition, articular cartilage isaneural, avascular, and alymphatic. In adult humans, this cartilagederives its nutrition by a double diffusion system through the synovialmembrane and through the dense matrix of the cartilage to reach thechondrocyte, the cells that are found in the connective tissue ofcartilage.

Adult cartilage has a limited ability of repair; thus, damage tocartilage produced by disease, such as rheumatoid and/or osteoarthritis,or trauma can lead to serious physical deformity and debilitation.Furthermore, as human articular cartilage ages, its tensile propertieschange. The superficial zone of the knee articular cartilage exhibits anincrease in tensile strength up to the third decade of life, after whichit decreases markedly with age as detectable damage to type II collagenoccurs at the articular surface. The deep zone cartilage also exhibits aprogressive decrease in tensile strength with increasing age, althoughcollagen content does not appear to decrease. These observationsindicate that there are changes in mechanical and, hence, structuralorganization of cartilage with aging that, if sufficiently developed,can predispose cartilage to traumatic damage.

For example, the superficial zone of the knee articular cartilageexhibits an increase in tensile strength up to the third decade of life,after which it decreases markedly with age as detectable damage to typeII collagen occurs at the articular surface. The deep zone cartilagealso exhibits a progressive decrease in tensile strength with increasingage, although collagen content does not appear to decrease. Theseobservations indicate that there are changes in mechanical and, hence,structural organization of cartilage with aging that, if sufficientlydeveloped, can predispose cartilage to traumatic damage.

Once damage occurs, joint repair can be addressed through a number ofapproaches. One approach includes the use of matrices, tissue scaffoldsor other carriers implanted with cells (e.g., chondrocytes, chondrocyteprogenitors, stromal cells, mesenchymal stem cells, etc.). However,clinical outcomes with biologic replacement materials such as allograftand autograft systems and tissue scaffolds have been uncertain sincemost of these materials cannot achieve a morphologic arrangement orstructure similar to or identical to that of normal, disease-free humantissue it is intended to replace. Moreover, the mechanical durability ofthese biologic replacement materials remains uncertain.

Usually, severe damage or loss of cartilage is treated by replacement ofthe joint with a prosthetic material, for example, silicone, e.g. forcosmetic repairs, or metal alloys. Implantation of these prostheticdevices is usually associated with loss of underlying tissue and bonewithout recovery of the full function allowed by the original cartilageand, with some devices, serious long-term complications associated withthe loss of significant amount of tissue and bone can include infection,osteolysis and also loosening of the implant.

As can be appreciated, joint arthroplasties are highly invasive andrequire surgical resection of the entire, or a majority of the,articular surface of one or more bones involved in the repair. Typicallywith these procedures, the marrow space is fairly extensively reamed inorder to fit the stem of the prosthesis within the bone. Reaming resultsin a loss of the patient's bone stock and over time subsequentosteolysis will frequently lead to loosening of the prosthesis. Further,the area where the implant and the bone mate degrades over timerequiring the prosthesis to eventually be replaced. Since the patient'sbone stock is limited, the number of possible replacement surgeries isalso limited for joint arthroplasty. In short, over the course of 15 to20 years, and in some cases even shorter time periods, the patient canrun out of therapeutic options ultimately resulting in a painful,non-functional joint.

A variety of tools, such as a guide for making one or more surgicalcuts, are currently available to assist surgeons. However, these devicesare not designed to substantially conform to the actual shape (contour)of the remaining cartilage in vivo and/or the underlying bone. Thus, useand proper alignment of the tool and integration of the implant can beextremely difficult due to differences in thickness and curvaturebetween the patient's surrounding cartilage and/or the underlyingsubchondral bone and the prosthesis. Thus, there remains a need fortools that increase the accuracy of cuts made to the bone in a joint inpreparation for surgical implantation of, for example, an artificialjoint.

SUMMARY OF THE INVENTION

The present invention provides novel surgical tools and methods. Inaccordance with one embodiment of the invention, a surgical toolincludes a template. The template has at least one contact surface forengaging a surface associated with a joint. The at least one contactsurface substantially conforms with the surface. The template furtherincludes at least one guide aperture for directing movement of asurgical instrument.

One embodiment is a system for articular repair that includes a firsttemplate having a first surface and a second surface, the first surfaceconforming with, and substantially a negative of, at least a portion offirst side of a joint; a second template having a third surface thatconforms with, and is substantially a negative of, a portion of thefirst side of the joint, the second template including at least oneguide for guiding a surgical instrument in making a cut on the firstside of the joint; and an attachment mechanism for attaching the secondtemplate to the first template.

Other embodiments may include one or more of the following. The first orsecond template can include a guide for making a vertical cut. Thesecond surface can be at least one of substantially flat, substantiallyconcave, substantially convex, and matched to one of the first or secondsides of the joint. The system can include at least one other template,and each of the other templates can be capable of attaching to thesecond template. The templates can vary in thickness. At least a portionof the first surface can substantially conforms to at least one of uncutsubchondral bone, uncut cartilage, and uncut bone of a first or secondside of the joint. At least a portion of the second surface cansubstantially conform to at least one of uncut subchondral bone, uncutcartilage, and uncut bone of a first or second side of a joint. At leasta portion of the third surface can substantially conforms to at leastone of uncut subchondral bone, uncut cartilage, and uncut bone of afirst or second side of a joint. The attachment mechanism can include atleast one of a snapfit, dovetail and a cross-pin. The attachmentmechanism can allow for rotation relative to one of an anatomical and abiomechanical axis. The joint can be at least one of a hip, knee, ankle,toe joint, shoulder, elbow, wrist, finger joint, spine or spinal joint.

Another embodiment is a system for articular joint repair that includes:a first template having a first surface and a second surface, the firstsurface substantially a negative of at least a portion of the tibialplateau; a second template having a third surface that is substantiallya negative of a portion of the tibia, the second template including atleast one guide for guiding a surgical instrument in making a cut on thetibia; and an attachment mechanism for attaching the second template tothe first template.

Other aspects of this embodiment may include one or more of thefollowing. The first or second template can include a guide for making avertical tibial cut. The second surface can be at least one ofsubstantially flat, substantially concave, substantially convex, andmatched to one of the tibia and the femur. The system can include atleast one other template can have a first surface and a second surface.The first surface can conform with, and be substantially a negative of,at least a portion of the tibial plateau. Each of the other templatescan be capable of attaching to the second template, wherein the firsttemplate and each of the other templates vary in thickness. At least aportion of the first surface can be substantially a negative of at leastone of uncut subchondral bone, uncut cartilage, and uncut bone of atibia. At least a portion of the second surface can be substantially anegative of at least one of uncut subchondral bone, uncut cartilage, anduncut bone of a tibia. At least a portion of the third surface can besubstantially a negative of at least one of uncut subchondral bone,uncut cartilage, and uncut bone of a tibia. The attachment mechanism caninclude at least one of a snapfit, dovetail and a cross-pin. Theattachment mechanism can allow for rotation relative to one of ananatomical and a biomechanical axis. At least one guide can guides asurgical instrument in making a cut on the tibia having a desired sloperelative to at least one of a biomechanical and an anatomical axis. Thearticular joint repair can be a joint resurfacing, including a kneejoint resurfacing, a joint replacement or other procedure.

Another embodiment is a system for articular repair that includes afirst template having a first surface substantially matching at least aportion of the tibial plateau. The first template can include a medialedge that corresponds to a predetermined location for a vertical tibialcut.

Other embodiments may have one or more of the following. A secondtemplate can have a surface substantially matching at least a portion ofthe tibia, and can include at least one guide for guiding a surgicalinstrument. The second template can also have an attachment mechanismfor attaching the second template to the first template. The firsttemplate can include a guide for guiding a surgical instrument. Themedial edge can be adapted as a guide for making a vertical tibial cut.The system can have at least one other template having a first surfaceand a second surface. The first surface can substantially match at leasta portion of the tibial plateau. The first template and each of theother templates can vary in thickness. At least a portion of the firstsurface can substantially match at least one of uncut subchondral bone,uncut cartilage, and uncut bone.

Another embodiment is a kit for testing at least one of ligamentbalancing and ligament tension, which includes a first template that hasat least one surface substantially conforming with at least a portion ofa first articular joint surface. The template is configured forplacement on the first articular joint surface and between the firstarticular joint surface and a second articular joint surface, and it hasa predefined thickness configured to provide a physical spacer forassessing at least one of ligament balance and ligament tension during asurgical procedure.

Other embodiments can include one or more of the following. The kit caninclude a second template that has at least one surface substantiallyconforming with at least the portion of the first articular jointsurface. The template can be configured for placement on the firstarticular joint surface and between the first articular joint surfaceand the second articular joint surface. The template can have a secondpredefined thickness configured to provide a physical spacer forassessing at least one of ligament balance and ligament tension during asurgical procedure. The kit can also include additional templates ofvarying thicknesses. The second template can also have at least oneguide for guiding a surgical instrument, and an attachment mechanism forattaching the second template to at least one of the first template andthe at least one other template. The kit can be used for articularjoints, including a knee joint, a hip joint, a shoulder joint, an elbowjoint, a wrist joint, a finger joint, a toe joint, and an ankle joint.At least a portion of the surface can substantially conforms to at leastone of uncut subchondral bone, uncut cartilage, and uncut bone.

Another embodiment is a method of partial or total knee replacement orresurfacing that includes: positioning a first surface of a firstinstrument onto at least a portion of the tibial plateau, the firstsurface being substantially a negative of at least a portion of thetibial plateau; cross-referencing a second instrument to the firstinstrument to align position of the second instrument on the tibia, thesecond instrument including at least one surgical cut guide; anddirecting a cut using the at least one surgical guide of the second ofthe second instrument.

Other embodiments can have one or more of the following. The cut can bea tibial cut. The instruments can be templates, surgical tools or otherdevices. The first instrument can include a guide for making a cut,which can be a vertical or horizontal cut, e.g., on the tibia. The firstinstrument can include a medial edge that corresponds to a predeterminedlocation for a vertical tibial cut, the method further comprisingconfirming the proper location of the vertical tibial cut based on themedial edge. At least a portion of the first surface can substantiallyconform to at least one of uncut subchondral bone, uncut cartilage, anduncut bone. The first surface of the instrument is based, at least inpart, on electronic image data of the tibial plateau. Cross-referencingcan include attaching the first instrument to the second instrument. Theat least one guide of the second instrument can guide a surgicalinstrument in making a cut on the tibia having a desired slope relativeto at least one of a biomechanical and an anatomical axis.

Another embodiment is a method for testing at least one of ligamentbalancing and ligament tension of a joint that includes: inserting afirst template having a first surface onto a first joint surface, thefirst surface substantially conforming to the first joint surface; andinserting a second template onto the first joint surface, the secondtemplate having a first surface that conforms with, and is substantiallya negative of, the first joint surface, the second template having athickness that varies from the first template.

Other embodiments can include one or more of the following. The methodcan further include selecting one of the first and second templatesbased on at least one of ligament balancing and ligament tension. Themethod can also include attaching a third template to the selectedtemplate, the third template, including at least one guide for guiding asurgical instrument; positioning the first surface of the selectedtemplate onto the first joint surface; and guiding the surgicalinstrument using the at least one guide. The joint can be one of a kneejoint, a hip joint, a shoulder joint, an elbow joint, a wrist joint, afinger joint, a toe joint, and an ankle joint.

Another embodiment is a system for articular repair that includes firstand second templates having a first surface that conforms with, andsubstantially is a negative of, at least a portion of a distal femur. Italso includes a second template that has a third surface that conformswith, and is substantially a negative of, a portion of the distal femur.The second template can include at least one guide for guiding asurgical instrument in making a cut on the distal femur, and anattachment mechanism for attaching the second template to the firsttemplate.

Other embodiments can include one or more of the following. The first orsecond templates can include a guide for making a vertical femoral cut.The second surface can be at least one of substantially flat,substantially concave, substantially convex, and matched to one of thetibia and the femur. At least one other template can have a firstsurface that conforms with, and substantially is a negative of, the atleast a portion of the distal femur. Each of the other templates can becapable of attaching to the second template. The first template and eachof the other templates can vary in thickness. At least a portion of thefirst surface can substantially conform to at least one of uncutsubchondral bone, uncut cartilage, and uncut bone of a distal femur. Atleast a portion of the second surface can substantially conform to atleast one of uncut subchondral bone, uncut cartilage, and uncut bone ofa distal femur. At least a portion of the third surface cansubstantially conform to at least one of uncut subchondral bone, uncutcartilage, and uncut bone of a tibia. The attachment mechanism caninclude at least one of a snapfit, dovetail and a cross-pin. Theattachment mechanism can allow for rotation relative to one of ananatomical and a biomechanical axis.

Another embodiment is a system for articular repair that includes afirst template having a first surface and a second surface, the firstsurface substantially conforming to at least a portion of the distalfemur. The first template includes a medial edge that corresponds to apredetermined location for a vertical femoral or tibial cut.

Other embodiments can have one or more of the following. A secondtemplate can have a third surface substantially conforming to at least aportion of the distal femur or tibial plateau. The second template caninclude at least one guide for guiding a surgical instrument. There canalso be an attachment mechanism for attaching the second template to thefirst template. The first template can include a guide for guiding asurgical instrument. The medial edge can be adapted as a guide formaking a vertical tibial or femoral cut. At least one other template canhave a first surface and a second surface. The first surface cansubstantially conform to at least a portion of the tibial plateau. Thefirst template and each of the other templates can vary in thickness. Atleast a portion of the first surface can substantially conforms to atleast one of uncut subchondral bone, uncut cartilage, and uncut bone.

Some embodiments can be used for a partial joint replacement, a totaljoint replacement, a partial joint resurfacing and a total jointresurfacing. Templates can vary in thickness or curvatures or can bemade available in multiple different thicknesses or curvatures. Thethickness of the other template can be selected to improve or optimizethe position of a bone cut for ligament balancing.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing features of the invention will be more readily understoodby reference to the following detailed description, taken with referenceto the accompanying drawings, in which:

FIG. 1 A illustrates a femur, tibia and fibula along with the mechanicaland anatomic axes. FIGS. 1 B-E illustrate the tibia with the anatomicand mechanical axis used to create a cutting plane along with a cutfemur and tibia. FIG. 1 F illustrates the proximal end of the femurincluding the head of the femur.

FIG. 2 shows an example of a surgical tool having one surface matchingthe geometry of an articular surface of the joint, in accordance withone embodiment of the invention. Also shown is an aperture in the toolcapable of controlling drill depth and width of the hole and allowingimplantation of an insertion of implant having a press-fit design.

FIG. 3 is a flow chart depicting various methods of the invention usedto create a mold for preparing a patient's joint for arthroscopicsurgery, in accordance with one embodiment of the invention.

FIG. 4 A depicts, in cross-section, an example of a surgical toolcontaining an aperture through which a surgical drill or saw can fit, inaccordance with one embodiment of the invention. The aperture guides thedrill or saw to make the proper hole or cut in the underlying bone.Dotted lines represent where the cut corresponding to the aperture willbe made in bone. FIG. 4 B depicts, in cross-section, an example of asurgical tool containing apertures through which a surgical drill or sawcan fit and which guide the drill or saw to make cuts or holes in thebone, in accordance with one embodiment of the invention. Dotted linesrepresent where the cuts corresponding to the apertures will be made inbone.

FIGS. 5 A-R illustrate tibial cutting blocks and molds used to create asurface perpendicular to the anatomic axis for receiving the tibialportion of a knee implant, in accordance with various embodiments of theinvention.

FIGS. 6 A-O illustrate femur cutting blocks and molds used to create asurface for receiving the femoral portion of a knee implant, inaccordance with various embodiments of the invention. FIG. 6 Pillustrates an axis defined by the center of the tibial plateau and thecenter of the distal tibia. FIG. 6 q shows an axis defining the centerof the tibial plateau to the femoral head. FIGS. 6 R and 6 S showisometric views of a femoral template and a tibial template,respectively, in accordance with various embodiments of the invention.FIG. 6 T illustrates a femoral guide reference tool attached to thefemoral template, in accordance with an embodiment of the invention.FIG. 6 U illustrates a sample implant template positioned on thechondyle, in accordance with an embodiment of the invention. FIG. 6 V isan isometric view of the interior surface of the sample implanttemplate, in accordance with an embodiment of the invention. FIG. 6 W isan isometric view of the tibial template attached to the sample implant,in accordance with an embodiment of the invention. FIG. 6 X shows atibial template that may be used, after the tibial cut has been made, tofurther guide surgical tools, in accordance with an embodiment of theinvention. FIG. 6 Y shows a tibial implant and femoral implant insertedonto the tibia and femur, respectively, after the above-described cutshave been made, in accordance with an embodiment of the invention.

FIG. 7 illustrates a femoral balancing template on a femur, inaccordance with one embodiment of the invention.

FIG. 8 illustrates a knee in balanced extension with femoral balancingtemplate fitted on the femoral condyle, in accordance with an embodimentof the invention.

FIG. 9 illustrates a tibial cutting guide fitted to the tibia whenbalanced in extension, in accordance with an embodiment of theinvention.

FIGS. 10 and 11 illustrate the tibial cutting guide pinned in place, inaccordance with an embodiment of the invention.

FIG. 12 illustrates the tibial cutting guide with femoral balancingtemplate removed, in accordance with an embodiment of the invention.

FIG. 13 illustrates the coronal tibial cut being made, in accordancewith an embodiment of the invention.

FIGS. 14 and 15 illustrate the use of a patient-specific vertical cutalignment tool to place the vertical tibial cut, in accordance with anembodiment of the invention.

FIGS. 16-23 illustrate the procedure and tools for installing thefemoral implant

FIG. 24 shows the femoral guide removed, and a trough for the anteriormargin of the femoral implant, in accordance with an embodiment of theinvention.

FIGS. 25-28 illustrate a procedure and tools for installing the tibialimplant, in accordance with an embodiment.

FIG. 29 illustrates a fin created using an osteotome, in accordance withan embodiment of the invention.

FIG. 30 shows a tibial cut guide pinned in extension, in accordance withone embodiment of the invention.

FIG. 31 shows the femoral balancing template removed, the patientspecific alignment tool positioned on the tibial plateau, and a cuttingguide attached to the tibia, in accordance with one embodiment of theinvention.

FIG. 32 shows a kit that may be provided with the resurfacing implantsand disposable instrumentation in a single sterile tray, in accordancewith one embodiment of the invention.

FIG. 33 shows cartilage removal on the condyle, in accordance with oneembodiment of the invention.

FIG. 34 shows cartilage removal on the condyle, in accordance with oneembodiment of the invention.

FIG. 35 shows an exemplary navigation chip, in accordance with oneembodiment of the invention.

FIG. 36 shows a navigation chip in-situ, in accordance with oneembodiment of the invention.

FIG. 37 shows the tibial jig placed in the knee, in accordance with oneembodiment of the invention.

FIG. 38 shows confirmation of the tibial cut planes, in accordance withone embodiment of the invention.

FIG. 39 shows the tibial axial cut, in accordance with one embodiment ofthe invention.

FIG. 40 shows the femoral jig placed on the distal femur, in accordancewith one embodiment of the invention.

FIG. 41 shows the posterior femoral cut performed, in accordance withone embodiment of the invention.

FIG. 42 shows flexion and extension balance verification, in accordancewith one embodiment of the invention.

FIG. 43 shows tibial template placement, in accordance with oneembodiment of the invention.

FIG. 44 shows the implants being cemented, in accordance with oneembodiment of the invention.

FIG. 45 shows the implants cemented in place, in accordance with oneembodiment of the invention.

DETAILED DESCRIPTION OF THE INVENTION

The following description is presented to enable any person skilled inthe art to make and use the invention. Various modifications to theembodiments described will be readily apparent to those skilled in theart, and the generic principles defined herein can be applied to otherembodiments and applications without departing from the spirit and scopeof the present invention as defined by the appended claims. Thus, thepresent invention is not intended to be limited to the embodimentsshown, but is to be accorded the widest scope consistent with theprinciples and features disclosed herein. To the extent necessary toachieve a complete understanding of the invention disclosed, thespecification and drawings of all issued patents, patent publications,and patent applications cited in this application are incorporatedherein by reference.

3D guidance surgical tools, referred to herein as a 3D guidance surgicaltemplates, that may be used for surgical assistance may include, withoutlimitation, using templates, jigs and/or molds, including 3D guidancemolds. It is to be understood that the terms “template,” “jig,” “mold,”“3D guidance mold,” and “3D guidance template,” shall be usedinterchangeably within the detailed description and appended claims todescribe the tool unless the context indicates otherwise.

3D guidance surgical tools that may be used may include guide apertures.It is to be understood that the term guide aperture shall be usedinterchangeably within the detailed description and appended claims todescribe both guide surface and guide elements.

As will be appreciated by those of skill in the art, the practice of thepresent invention employs, unless otherwise indicated, conventionalmethods of x-ray imaging and processing, x-ray tomosynthesis, ultrasoundincluding A-scan, B-scan and C-scan, computed tomography (CT scan),magnetic resonance imaging (MRI), optical coherence tomography, singlephoton emission tomography (SPECT) and positron emission tomography(PET) within the skill of the art. Such techniques are explained fullyin the literature and need not be described herein. See, e.g., X-RayStructure Determination: A Practical Guide, 2nd Edition, editors Stoutand Jensen, 1989, John Wiley & Sons, publisher; Body CT: A PracticalApproach, editor Slone, 1999, McGraw-Hill publisher; X-ray Diagnosis: APhysician's Approach, editor Lam, 1998 Springer-Verlag, publisher; andDental Radiology: Understanding the X-Ray Image, editor LaetitiaBrocklebank 1997, Oxford University Press publisher. See also, TheEssential Physics of Medical Imaging (2^(nd) Ed.), Jerrold T. Bushberg,et al.

A. The Joint Replacement Procedure

The present invention may be applied to all joints, such as, withoutlimitation, the knee, hip, shoulder, elbow, wrist, finger, toe, andankle. Illustratively, the knee and hip joint procedures are discussedbelow, so as to teach the concept of the design as it would then applyto other joints in the body.

All of the embodiments described herein are applicable partial jointreplacement, total joint replacement, and hemiarthroplasty. Theembodiments may be combined with standard instrumentation known in theart as well as surgical techniques and robotics known in the art.

i. Knee Joint

Performing a total knee arthroplasty is a complicated procedure. Inreplacing the knee with an artificial knee, it is important to get theanatomical and mechanical axes of the lower extremity aligned correctlyto ensure optimal functioning of the implanted knee.

As shown in FIG. 1 A, the center of the hip 1902 (located at the head1930 of the femur 1932), the center of the knee 1904 (located at thenotch where the intercondular tubercle 1934 of the tibia 1936 meet thefemur) and ankle 1906 lie approximately in a straight line 1910 whichdefines the mechanical axis of the lower extremity. The anatomic axis1920 aligns 5-7° offset θ from the mechanical axis in the valgus, oroutward, direction.

The long axis of the tibia 1936 is collinear with the mechanical axis ofthe lower extremity 1910. From a three-dimensional perspective, thelower extremity of the body ideally functions within a single planeknown as the median anterior-posterior plane (MAP-plane) throughout theflexion-extension arc. In order to accomplish this, the femoral head1930, the mechanical axis of the femur, the patellar groove, theintercondylar notch, the patellar articular crest, the tibia and theankle remain within the MAP-plane during the flexion-extension movement.During movement, the tibia rotates as the knee flexes and extends in theepicondylar axis which is perpendicular to the MAP-plane.

A variety of image slices can be taken at each individual joint, e.g.,the knee joint 1950-1950 _(n), and the hip joint 1952-1950 _(n). Theseimage slices can be used as described above in Section I along with animage of the full leg to ascertain the axis.

With disease and malfunction of the knee, alignment of the anatomic axisis altered. Performing a total knee arthroplasty is one solution forcorrecting a diseased knee. Implanting a total knee joint, such as thePFC Sigma RP Knee System by Johnson & Johnson, requires that a series ofresections be made to the surfaces forming the knee joint in order tofacilitate installation of the artificial knee. The resections should bemade to enable the installed artificial knee to achieveflexion-extension movement within the MAP-plane and to optimize thepatient's anatomical and mechanical axis of the lower extremity.

First, the tibia 1930 is resected to create a flat surface to accept thetibial component of the implant. In most cases, the tibial surface isresected perpendicular to the long axis of the tibia in the coronalplane, but is typically sloped 4-7° posteriorly in the sagittal plane tomatch the normal slope of the tibia. As will be appreciated by those ofskill in the art, the sagittal slope can be 0° where the device to beimplanted does not require a sloped tibial cut. The resection line 1958is perpendicular to the mechanical axis 1910, but the angle between theresection line and the surface plane of the plateau 1960 variesdepending on the amount of damage to the knee.

FIGS. 1 B-D illustrate an anterior view of a resection of ananatomically normal tibial component, a tibial component in a varusknee, and a tibial component in a valgus knee, respectively. In eachfigure, the mechanical axis 1910 extends vertically through the bone andthe resection line 1958 is perpendicular to the mechanical axis 1910 inthe coronal plane, varying from the surface line formed by the jointdepending on the amount of damage to the joint. FIG. 1 B illustrates anormal knee wherein the line corresponding to the surface of the joint1960 is parallel to the resection line 1958. FIG. 1 C illustrates avarus knee wherein the line corresponding to the surface of the joint1960 is not parallel to the resection line 1958. FIG. 1 D illustrates avalgus knee wherein the line corresponding to the surface of the joint1960 is not parallel to the resection line 1958.

Once the tibial surface has been prepared, the surgeon turns topreparing the femoral condyle.

The plateau of the femur 1970 is resected to provide flat surfaces thatcommunicate with the interior of the femoral prosthesis. The cuts madeto the femur are based on the overall height of the gap to be createdbetween the tibia and the femur. Typically, a 20 mm gap is desirable toprovide the implanted prosthesis adequate room to achieve full range ofmotion. The bone is resected at a 5-7° angle valgus to the mechanicalaxis of the femur. Resected surface 1972 forms a flat plane with anangular relationship to adjoining surfaces 1974, 1976. The angle θ′, θ″between the surfaces 1972-1974, and 1972-1976 varies according to thedesign of the implant.

ii. Hip Joint

As illustrated in FIG. 1 F, the external geometry of the proximal femurincludes the head 1980, the neck 1982, the lesser trochanter 1984, thegreater trochanter 1986 and the proximal femoral diaphysis. The relativepositions of the trochanters 1984, 1986, the femoral head center 1902and the femoral shaft 1988 are correlated with the inclination of theneck-shaft angle. The mechanical axis 1910 and anatomic axis 1920 arealso shown. Assessment of these relationships can change the reamingdirection to achieve neutral alignment of the prosthesis with thefemoral canal.

Using anteroposterior and lateral radiographs, measurements are made ofthe proximal and distal geometry to determine the size and optimaldesign of the implant.

Typically, after obtaining surgical access to the hip joint, the femoralneck 1982 is resected, e.g. along the line 1990. Once the neck isresected, the medullary canal is reamed. Reaming can be accomplished,for example, with a conical or straight reamer, or a flexible reamer.The depth of reaming is dictated by the specific design of the implant.Once the canal has been reamed, the proximal reamer is prepared byserial rasping, with the rasp directed down into the canal.

B. Surgical Tools

Surgical assistance can be provided by using a device, referred to alsoherein as a surgical tool or template, applied to the outer surface ofthe articular cartilage or the bone, including the subchondral bone, inorder to match the alignment of the articular repair system and therecipient site or the joint. The template may be round, circular, oval,ellipsoid, curved or irregular in shape. The shape can be selected oradjusted to match or enclose an area of diseased cartilage or an areaslightly larger than the area of diseased cartilage or substantiallylarger than the diseased cartilage. The area can encompass the entirearticular surface or the weight bearing surface. Such devices aretypically preferred when replacement of a majority or an entirearticular surface is contemplated.

The template may include at least one guide for guiding a surgicalinstrument. The at least one guide may direct the surgical instrument inat least one of a cut, a milling, and a drilling. The at least one guidemay be, without limitation, a drill hole, a cut planes, a saw plane andthe like. The guide may be oriented in a predefined location relativeto, without limitation, the contact surface of the template with thearticular cartilage or bone, and may be adapted in shape, size ororientation to an implant shape.

Typically, a position of the guide will be chosen that will result in ananatomically desirable cut plane, drill hole, or general instrumentorientation for subsequent placement of an articular repair system orfor facilitating placement of the articular repair system. Moreover, thetemplate may be designed so that the depth of the drill, reamer or othersurgical instrument can be controlled, e.g., the drill cannot go anydeeper into the tissue than defined by the device, and the size of thehole in the block can be designed to essentially match the size of theimplant. Information about other joints or axis and alignmentinformation of a joint or extremity can be included when selecting theposition of these slots or holes. Alternatively, the openings in thetemplate may be made larger than needed to accommodate theseinstruments. The template may also be configured to conform to thearticular shape. The apertures, or openings, provided can be wide enoughto allow for varying the position or angle of the surgical instrument,e.g., reamers, saws, drills, curettes and other surgical instruments. Aninstrument guide, typically comprised of a relatively hard material, canthen be applied to the device. The device helps orient the instrumentguide relative to the three-dimensional anatomy of the joint.

The template may be a mold that can be made of a plastic or polymer. Thetemplate may be produced by rapid prototyping technology, in whichsuccessive layers of plastic are laid down, as know in the art. In otherembodiments, the template or portions of the template can be made ofmetal. The template can be milled or made using laser basedmanufacturing techniques.

The template may be casted using rapid prototyping and, for example,lost wax technique. It may also be milled. For example, a preformedtemplate with a generic shape can be used at the outset, which can thenbe milled to the patient specific dimensions. The milling may only occuron one surface of the template, preferably the surface that faces thearticular surface. Milling and rapid prototyping techniques may becombined.

Curable materials may be used which can be poured into forms that are,for example, generated using rapid prototyping. For example, liquidmetal may be used. Cured materials may optionally be milled or thesurface can be further refined using other techniques.

Metal inserts may be applied to plastic components. For example, aplastic mold may have at least one guide aperture to accept a reamingdevice or a saw. A metal insert may be used to provide a hard wall toaccept the reamer or saw. Using this or similar designs can be useful toavoid the accumulation of plastic or other debris in the joint when thesaw or other surgical instruments may get in contact with the mold.Other hard materials can be used to serve as inserts. These can alsoinclude, for example, hard plastics or ceramics.

In another embodiment, the template does not have metallic inserts toaccept a reaming device or saw. The metal inserts or guides may be partof an attached device that is typically in contact with the template. Ametallic drill guide or a metallic saw guide may thus, for example, havemetallic or hard extenders that reach through the mold thereby, forexample, also stabilizing any devices applied to the mold against thephysical body of the mold.

One or more templates can be used during the surgery. For example, inthe hip, a template can be initially applied to the proximal femur thatclosely approximates the 3D anatomy prior to the resection of thefemoral head. The template can include an opening to accommodate a saw.The opening is positioned to achieve an optimally placed surgical cutfor subsequent reaming and placement of the prosthesis. A secondtemplate can then be applied to the proximal femur after the surgicalcut has been made. The second template can be useful for guiding thedirection of a reamer prior to placement of the prosthesis. As can beseen in this, as well as in other examples, templates can be made forjoints prior to any surgical intervention. However, it is also possibleto make templates that are designed to fit to a bone or portions of ajoint after the surgeon has already performed selected surgicalprocedures, such as cutting, reaming, drilling, etc. The template canaccount for the shape of the bone or the joint resulting from theseprocedures.

Upon imaging, a physical template of a joint, such as a knee joint, orhip joint, or ankle joint or shoulder joint is generated, in accordancewith an embodiment of the invention. The template can be used to performimage guided surgical procedures such as partial or complete jointreplacement, articular resurfacing, or ligament repair. The template mayinclude reference points or opening or apertures for surgicalinstruments such as drills, saws, burrs and the like.

In order to derive the preferred orientation of drill holes, cut planes,saw planes and the like, openings or receptacles in said template orattachments will be adjusted to account for at least one axis. The axiscan be anatomic or biomechanical, for example, for a knee joint, a hipjoint, an ankle joint, a shoulder joint or an elbow joint.

In one embodiment, only a single axis is used for placing and optimizingsuch drill holes, saw planes, cut planes, and or other surgicalinterventions. This axis may be, for example, an anatomical orbiomechanical axis. In a preferred embodiment, a combination of axisand/or planes can be used for optimizing the placement of the drillholes, saw planes, cut planes or other surgical interventions. Forexample, two axes (e.g., one anatomical and one biomechanical) can befactored into the position, shape or orientation of the 3D guidedtemplate and related attachments or linkages. For example, two axes,(e.g., one anatomical and biomechanical) and one plane (e.g., the topplane defined by the tibial plateau), can be used. Alternatively, two ormore planes can be used (e.g., a coronal and a sagittal plane), asdefined by the image or by the patients anatomy.

Angle and distance measurements and surface topography measurements maybe performed in these one or more, preferably two or more, preferablythree or more multiple planes, as necessary. These angle measurementscan, for example, yield information on varus or valgus deformity,flexion or extension deficit, hyper or hypo-flexion or hyper- orhypo-extension, abduction, adduction, internal or external rotationdeficit, or hyper- or hypo-abduction, hyper- or hypo-adduction, hyper-or hypo-internal or external rotation.

Single or multi-axis line or plane measurements can then be utilized todetermine preferred angles of correction, e.g., by adjusting surgicalcut or saw planes or other surgical interventions. Typically, two axiscorrections will be preferred over a single axis correction, a two planecorrection will be preferred over a single plane correction and soforth.

In accordance with another embodiment of the invention, more than onedrilling, cut, boring and/or reaming or other surgical intervention isperformed for a particular treatment such as the placement of a jointresurfacing or replacing implant, or components thereof. These two ormore surgical interventions (e.g., drilling, cutting, reaming, sawing)are made in relationship to a biomechanical axis, and/or an anatomicalaxis and/or an implant axis. The 3D guidance template or attachments orlinkages thereto include two or more openings, guides, apertures orreference planes to make at least two or more drillings, reamings,borings, sawings or cuts in relationship to a biomechanical axis, ananatomical axis, an implant axis or other axis derived therefrom orrelated thereto.

While in simple embodiments it is possible that only a single cut ordrilling will be made in relationship to a biomechanical axis, ananatomical axis, an implant axis and/or an axis related thereto, in mostmeaningful implementations, two or more drillings, borings, reamings,cutting and/or sawings will be performed or combinations thereof inrelationship to a biomechanical, anatomical and/or implant axis.

FIG. 2 shows an example of a surgical tool 410 having one surface 400matching the geometry of an articular surface of the joint. Also shownis an aperture 415 in the tool 410 capable of controlling drill depthand width of the hole and allowing implantation or insertion of implant420 having a press-fit design.

FIG. 3 is a flow chart illustrating the steps involved in designing atemplate for use in preparing a joint surface. Illustratively, thetemplate is, without limitation, a mold. Optionally, the first step canbe to measure the size of the area of the diseased cartilage orcartilage loss 2100, Once the size of the cartilage loss has beenmeasured, the user can measure the thickness of the adjacent cartilage2120, prior to measuring the curvature of the articular surface and/orthe subchondral bone 2130. Alternatively, the user can skip the step ofmeasuring the thickness of the adjacent cartilage 2102. Once anunderstanding and determination of the shape of the subchondral bone isdetermined, either a mold can be selected from a library of molds 3132or a patient specific mold can be generated 2134. In either event, theimplantation site is then prepared 2140 and implantation is performed2142. Any of these steps can be repeated by the optional repeat steps2101, 2121, 2131, 2133, 2135, 2141.

Instead of a mold, it is to be understood that the surgical tool may bemade in a variety of ways, including, without limitation, machining andrapid prototyping. Rapid prototyping is a technique for fabricating athree-dimensional object from a computer model of the object. Typically,a special printer is used to fabricate the prototype from a plurality oftwo-dimensional layers. Computer software sections the representationsof the object into a plurality of distinct two-dimensional layers andthen a three-dimensional printer fabricates a layer of material for eachlayer sectioned by the software. Together the various fabricated layersform the desired prototype. More information about rapid prototypingtechniques is available in US Patent Publication No 2002/0079601A1 toRussell et al., published Jun. 27, 2002, which is incorporated herein byreference. An advantage to using rapid prototyping is that it enablesthe use of free form fabrication techniques that use toxic or potentcompounds safely. These compounds can be safely incorporated in anexcipient envelope, which reduces worker exposure

A variety of techniques can be used to derive the shape of the template,as described above. For example, a few selected CT slices through thehip joint, along with a full spiral CT through the knee joint and a fewselected slices through the ankle joint can be used to help define theaxes if surgery is contemplated of the knee joint. Once the axes aredefined, the shape of the subchondral bone can be derived, followed byapplying standardized cartilage loss.

Methodologies for stabilizing the 3D guidance templates will now bedescribed. The 3D guide template may be stabilized using multiplesurgical tools such as, without limitation: K-wires; a drill bitanchored into the bone and left within the template to stabilize itagainst the bone; one or more convexities or cavities on the surfacefacing the cartilage; bone stabilization against intra/extra articularsurfaces, optionally with extenders, for example, from an articularsurface onto an extra-articular surface; and/or stabilization againstnewly placed cuts or other surgical interventions.

Specific anatomic landmarks may be selected in the design and make ofthe 3D guide template in order to further optimize the anatomicstabilization. For example, a 3D guidance template may be designed tocover portions or all off an osteophyte or bone spur in order to enhanceanchoring of the 3D guide template against the underlying articularanatomy. The 3D guidance template may be designed to the shape of atrochlear or intercondylar notch and can encompass multiple anatomicareas such as a trochlea, a medial and a lateral femoral condyle at thesame time. In the tibia, a 3D guide template may be designed toencompass a medial and lateral tibial plateau at the same time and itcan optionally include the tibial spine for optimized stabilization andcross-referencing. In a hip, the fovea capitis may be utilized in orderto stabilize a 3D guide template. Optionally, the surgeon may elect toresect the ligamentum capitis femoris in order to improve thestabilization. Also in the hip, an acetabular mold can be designed toextend into the region of the tri-radiate cartilage, the medial,lateral, superior, inferior, anterior and posterior acetabular wall orring. By having these extensions and additional features forstabilization, a more reproducible position of the 3D template can beachieved with resulted improvement in accuracy of the surgicalprocedure. Typically, a template with more than one convexity orconcavity or multiple convexities or concavities will provide bettercross-referencing in the anatomic surface and higher accuracy and higherstabilization than compared to a mold that has only few surface featuressuch as a singular convexity. Thus, in order to improve theimplementation and intraoperative accuracy, careful surgical planningand preoperative planning is desired, that encompasses preferably morethan one convexity, more preferred more than two convexities and evenmore preferred more than three convexities, or that encompasses morethan one concavity, more preferred more than two concavities or evenmore preferred more than three concavities on an articular surface oradjoined surface, including bone and cartilage outside theweight-bearing surface.

In an even more preferred embodiment, more than one convexity andconcavity, more preferred more than two convexities and concavities andeven more preferred more then three convexities and concavities areincluded in the surface of the mold in order to optimize theinteroperative cross-referencing and in order to stabilize the moldprior to any surgical intervention.

Turning now to a particular 3D surgical template configuration for aspecific joint application (knee joint), which is intended to teach theconcept of the design as it would then apply to other joints in thebody:

When a total knee arthroplasty is contemplated, the patient can undergoan imaging test, that will demonstrate the articular anatomy of a kneejoint, e.g. width of the femoral condyles, the tibial plateau etc.Additionally, other joints can be included in the imaging test therebyyielding information on femoral and tibial axes, deformities such asvarus and valgus and other articular alignment. The imaging test may be,without limitation, an x-ray image, preferably in standing, load-bearingposition, a CT or spiral CT scan or an MRI scan or combinations thereof.A spiral CT scan may be advantageous over a standard CT scan due to itsimproved spatial resolution in z-direction in addition to x and yresolution. The articular surface and shape as well as alignmentinformation generated with the imaging test can be used to shape thesurgical assistance device, to select the surgical assistance devicefrom a library of different devices with pre-made shapes and sizes, orcan be entered into the surgical assistance device and can be used todefine the preferred location and orientation of saw guides or drillholes or guides for reaming devices or other surgical instruments.Intraoperatively, the surgical assistance device is applied to thetibial plateau and subsequently the femoral condyle(s) by matching itssurface with the articular surface or by attaching it to anatomicreference points on the bone or cartilage. The surgeon can thenintroduce a reamer or saw through the guides and prepare the joint forthe implantation. By cutting the cartilage and bone along anatomicallydefined planes, a more reproducible placement of the implant can beachieved. This can ultimately result in improved postoperative resultsby optimizing biomechanical stresses applied to the implant andsurrounding bone for the patient's anatomy and by minimizing axismalalignment of the implant. In addition, the surgical assistance devicecan greatly reduce the number of surgical instruments needed for totalor unicompartmental knee arthroplasty. Thus, the use of one or moresurgical assistance devices can help make joint arthroplasty moreaccurate, improve postoperative results, improve long-term implantsurvival, reduce cost by reducing the number of surgical instrumentsused. Moreover, the use of one or more surgical assistance device canhelp lower the technical difficulty of the procedure and can helpdecrease operating room (“OR”) times.

Thus, surgical tools described herein can also be designed and used tocontrol drill alignment, depth and width, for example when preparing asite to receive an implant. For example, the tools described herein,which typically conform to the joint surface, can provide for improveddrill alignment and more accurate placement of any implant. Ananatomically correct tool can be constructed by a number of methods andcan be made of any material, preferably a substantially translucentand/or transparent material such as plastic, Lucite, silastic, SLA orthe like, and typically is a block-like shape prior to molding.

FIG. 4 A depicts, in cross-section, an example of a template 600 for useon the tibial surface having an upper surface 620. The template 600includes an aperture 625 through which a surgical drill or saw can fit.The aperture guides the drill or saw to make the proper hole or cut inthe underlying bone 610 as illustrated in FIGS. 1 B-D. In variousembodiments, the template may include a guide aperture, a reamingaperture, a drill aperture and a cut plane for guiding a surgical tool.Dotted lines 632 illustrate where the cut corresponding to the aperturewill be made in bone. FIG. 4 B depicts, a template 608 suitable for useon the femur. As can be appreciated from this perspective, additionalapertures are provided to enable additional cuts to the bone surface.The apertures 605 enable cuts 606 to the surface of the femur. Theresulting shape of the femur corresponds to the shape of the interiorsurface of the femoral implant, typically as shown in FIG. 1 E.Additional shapes can be achieved, if desired, by changing the size,orientation and placement of the apertures. Such changes would bedesired where, for example, the interior shape of the femoral componentof the implant requires a different shape of the prepared femur surface.

Turning now to FIG. 5, a variety of illustrations are provided showing atemplate that includes a tibial cutting block and mold system. FIG. 5 Aillustrates the tibial cutting block 2300 in conjunction with a tibia2302 that has not been resected. In this depiction, the cutting block2300 consists of at least two pieces. The first piece is a patientspecific interior piece 2310 or mold that is designed on its inferiorsurface 2312 to mate, or substantially mate, with the existing geographyof the patient's tibia 2302. The superior surface 2314 and side surfaces2316 of the first piece 2310 are configured to mate within the interiorof an exterior piece 2320. The reusable exterior piece 2320 fits overthe interior piece 2310. The system can be configured to hold the moldonto the bone.

The reusable exterior piece has a superior surface 2322 and an inferiorsurface 2324 that mates with the first piece 2310. The reusable exteriorpiece 2320 includes cutting guides 2328, to assist the surgeon inperforming the tibial surface cut described above. As shown herein aplurality of cutting guides can be provided to provide the surgeon avariety of locations to choose from in making the tibial cut. Ifnecessary, additional spacers can be provided that fit between the firstpatient configured, or molded, piece 2310 and the second reusableexterior piece, or cutting block, 2320.

Clearly, the mold may be a single component or multiple components. In apreferred embodiment, one or more components are patient specific whileother components such as spacers or connectors to surgical instrumentsare generic. In one embodiment, the mold can rest on portions of thejoint on the articular surface or external to the articular surface.Other surgical tools then may connect to the mold. For example, astandard surgical cut block as described for standard implants, forexample in the knee the J&J PFC Sigma system, the Zimmer Nexgen systemor the Stryker Duracon system, can be connected or placed on the mold.In this manner, the patient specific component can be minimized and canbe made compatible with standard surgical instruments.

The mold may include receptacles for standard surgical instrumentsincluding alignment tools or guides. For example, a tibial mold for usein knee surgery may have an extender or a receptacle or an opening toreceive a tibial alignment rod. In this manner, the position of the moldcan be checked against the standard alignment tools and methods.Moreover, the combined use of molds and standard alignment toolsincluding also surgical navigation techniques can help improve theaccuracy of or optimize component placement in joint arthroplasty, suchas hip or knee arthroplasty. For example, the mold can help define thedepth of a horizontal tibial cut for placement of a tibial component. Atibial alignment guide, for example an extramedullary or intramedullaryalignment guide, used in conjunction with a tibial mold can help findthe optimal anteroposterior angulation, posterior slope, tibial slant,or varus-valgus angle of the tibial cut. The mold may be designed towork in conjunction with traditional alignment tools known in the art.

The template may include markers, e.g. optoelectronic or radiofrequency,for surgical navigation. The template may have receptacles to which suchmarkers can be attached, either directly or via a linking member.

The templates can be used in combination with a surgical navigationsystem. They can be used to register the bones associated with a jointinto the coordinate system of the surgical navigation system. Forexample, if a mold for a joint surface includes tracking markers forsurgical navigation, the exact position and orientation of the bone canbe detected by the surgical navigation system after placement of themold in its unique position. This helps to avoid the time-consuming needto acquire the coordinates of tens to hundreds of points on the jointsurface for registration.

Referring back to FIG. 5, the variable nature of the interior piecefacilitates obtaining the most accurate cut despite the level of diseaseof the joint because it positions the exterior piece 2320 such that itcan achieve a cut that is perpendicular to the mechanical axis. Eitherthe interior piece 2310 or the exterior piece 2320 can be formed out ofany of the materials discussed above in Section II, or any othersuitable material. Additionally, a person of skill in the art willappreciate that the invention is not limited to the two piececonfiguration described herein. The reusable exterior piece 2320 and thepatient specific interior piece 2310 can be a single piece that iseither patient specific (where manufacturing costs of materials supportsuch a product) or is reusable based on a library of substantiallydefect conforming shapes developed in response to known or common tibialsurface sizes and defects.

The interior piece 2310 is typically molded to the tibia including thesubchondral bone and/or the cartilage. The surgeon will typically removeany residual meniscal tissue prior to applying the mold. Optionally, theinterior surface 2312 of the mold can include shape information ofportions or all of the menisci.

Turning now to FIG. 5 B-D, a variety of views of the removable exteriorpiece 2320. The top surface 2322 of the exterior piece can be relativelyflat. The lower surface 2324 which abuts the interior piece conforms tothe shape of the upper surface of the interior piece. In thisillustration the upper surface of the interior piece is flat, thereforethe lower surface 2324 of the reusable exterior surface is also flat toprovide an optimal mating surface.

A guide plate 2326 is provided that extends along the side of at least aportion of the exterior piece 2320. The guide plate 2326 provides one ormore slots or guides 2328 through which a saw blade can be inserted toachieve the cut desired of the tibial surface. Additionally, the slot,or guide, can be configured so that the saw blade cuts at a lineperpendicular to the mechanical axis, or so that it cuts at a line thatis perpendicular to the mechanical axis, but has a 4-7° slope in thesagittal plane to match the normal slope of the tibia.

Optionally, a central bore 2330 can be provided that, for example,enables a drill to ream a hole into the bone for the stem of the tibialcomponent of the knee implant.

FIGS. 5 E-H illustrate the interior, patient specific, piece 2310 from avariety of perspectives. FIG. 5 E shows a side view of the piece showingthe uniform superior surface 2314 and the uniform side surfaces 2316along with the irregular inferior surface 2316. The inferior surfacemates with the irregular surface of the tibia 2302. FIG. 5 F illustratesa superior view of the interior, patient, specific piece of the mold2310. Optionally having an aperture 2330. FIG. 5 G illustrates aninferior view of the interior patient specific mold piece 2310 furtherillustrating the irregular surface which includes convex and concaveportions to the surface, as necessary to achieve optimal mating with thesurface of the tibia. FIG. 5 H illustrates cross-sectional views of theinterior patient specific mold piece 2310. As can be seen in thecross-sections, the surface of the interior surface changes along itslength.

As is evident from the views shown in FIGS. 5 B and D, the length of theguide plate 2326 can be such that it extends along all or part of thetibial plateau, e.g. where the guide plate 2326 is asymmetricallypositioned as shown in FIG. 5 B or symmetrical as in FIG. 3 D. If totalknee arthroplasty is contemplated, the length of the guide plate 2326typically extends along all of the tibial plateau. If unicompartmentalarthroplasty is contemplated, the length of the guide plate typicallyextends along the length of the compartment that the surgeon willoperate on. Similarly, if total knee arthroplasty is contemplated, thelength of the molded, interior piece 2310 typically extends along all ofthe tibial plateau; it can include one or both tibial spines. Ifunicompartmental arthroplasty is contemplated, the length of the moldedinterior piece typically extends along the length of the compartmentthat the surgeon will operate on; it can optionally include a tibialspine.

Turning now to FIG. 5 I, an alternative embodiment is depicted of theaperture 2330. In this embodiment, the aperture features lateralprotrusions to accommodate using a reamer or punch to create an openingin the bone that accepts a stem having flanges.

FIGS. 5 J and M depict alternative embodiments of the invention designedto control the movement and rotation of the cutting block 2320 relativeto the mold 2310. As shown in FIG. 5 J a series of protrusions,illustrated as pegs 2340, are provided that extend from the superiorsurface of the mold. As will be appreciated by those of skill in theart, one or more pegs or protrusions can be used without departing fromthe scope of the invention. For purposes of illustration, two pegs havebeen shown in FIG. 5 J. Depending on the control desired, the pegs 2340are configured to fit within, for example, a curved slot 2342 thatenables rotational adjustment as illustrated in FIG. 3 K or within arecess 2344 that conforms in shape to the peg 2340 as shown in FIG. 5 L.As will be appreciated by those of skill in the art, the recess 2344 canbe sized to snugly encompass the peg or can be sized larger than the pegto allow limited lateral and rotational movement. The recess can becomposed of a metal or other hard insert 544.

As illustrated in FIG. 5 M the surface of the mold 2310 can beconfigured such that the upper surface forms a convex dome 2350 thatfits within a concave well 2352 provided on the interior surface of thecutting block 2320. This configuration enables greater rotationalmovement about the mechanical axis while limiting lateral movement ortranslation.

Other embodiments and configurations could be used to achieve theseresults without departing from the scope of the invention.

As will be appreciated by those of skill in the art, more than twopieces can be used, where appropriate, to comprise the system. Forexample, the patient specific interior piece 2310 can be two pieces thatare configured to form a single piece when placed on the tibia.Additionally, the exterior piece 2320 can be two components. The firstcomponent can have, for example, the cutting guide apertures 2328. Afterthe resection using the cutting guide aperture 2328 is made, theexterior piece 2320 can be removed and a secondary exterior piece 2320′can be used which does not have the guide plate 2326 with the cuttingguide apertures 2328, but has the aperture 2330 which facilitates boringinto the tibial surface an aperture to receive a stem of the tibialcomponent of the knee implant. Any of these designs could also featurethe surface configurations shown in FIGS. 5 J-M, if desired.

FIG. 5 N illustrates an alternative design of the cutting block 2320that provides additional structures 2360 to protect, for example, thecruciate ligaments, from being cut during the preparation of the tibialplateau. These additional structures can be in the form of indentedguides 2360, as shown in FIG. 5 N or other suitable structures.

FIG. 5 O illustrates a cross-section of a system having anchoring pegs2362 on the surface of the interior piece 2310 that anchor the interiorpiece 2310 into the cartilage or meniscal area.

FIGS. 5 P AND Q illustrate a device 2300 configured to cover half of atibial plateau such that it is unicompartmental.

FIG. 5 R illustrates an interior piece 2310 that has multiple contactsurfaces 2312 with the tibial 2302, in accordance with one embodiment ofthe invention. As opposed to one large contact surface, the interiorpiece 2310 includes a plurality of smaller contact surfaces 2312. Invarious embodiments, the multiple contact surfaces 2312 are not on thesample plane and are at angles relative to each other to ensure properpositioning on the tibia 2302. Two or three contact surfaces 2312 may berequired to ensure proper positioning. In various embodiments, only thecontact surfaces 2312 of the interior piece may be molded, the moldsattached to the rest of the template using methodologies known in theart, such as adhesives. The molds may be removably attached to thetemplate. It is to be understood that multiple contact surfaces 2312 maybe utilized in template embodiments that include one or a plurality ofpieces.

Turning now to FIG. 6, a femoral template/mold system is depicted thatfacilitates preparing the surface of the femur such that the finallyimplanted femoral implant will achieve optimal mechanical and anatomicalaxis alignment.

FIG. 6 A illustrates the femur 2400 with a first portion 2410 of themold placed thereon. In this depiction, the top surface of the mold 2412is provided with a plurality of apertures. In this instance theapertures consist of a pair of rectangular apertures 2414, a pair ofsquare apertures 2416, a central bore aperture 2418 and a longrectangular aperture 2420. The side surface 2422 of the first portion2410 also has a rectangular aperture 2424. Each of the apertures islarger than the eventual cuts to be made on the femur so that, in theevent the material the first portion of the mold is manufactured from asoft material, such as plastic, it will not be inadvertently cut duringthe joint surface preparation process. Additionally, the shapes can beadjusted, e.g., rectangular shapes made trapezoidal, to give a greaterflexibility to the cut length along one area, without increasingflexibility in another area. As will be appreciated by those of skill inthe art, other shapes for the apertures, or orifices, can be changedwithout departing from the scope of the invention.

FIG. 6 B illustrates a side view of the first portion 2410 from theperspective of the side surface 2422 illustrating the aperture 2424. Asillustrated, the exterior surface 2411 has a uniform surface which isflat, or relatively flat configuration while the interior surface 2413has an irregular surface that conforms, or substantially conforms, withthe surface of the femur.

FIG. 6 c illustrates another side view of the first, patient specificmolded, portion 2410, more particularly illustrating the irregularsurface 2413 of the interior. FIG. 6 D illustrates the first portion2410 from a top view. The center bore aperture 2418 is optionallyprovided to facilitate positioning the first piece and to preventcentral rotation.

FIG. 6 D illustrates a top view of the first portion 2410. The bottom ofthe illustration corresponds to an anterior location relative to theknee joint. From the top view, each of the apertures is illustrated asdescribed above. As will be appreciated by those of skill in the art,the apertures can be shaped differently without departing from the scopeof the invention.

Turning now to FIG. 6 E, the femur 2400 with a first portion 2410 of thecutting block placed on the femur and a second, exterior, portion 2440placed over the first portion 2410 is illustrated. The second, exterior,portion 2440 features a series of rectangular grooves (2442-2450) thatfacilitate inserting a saw blade therethrough to make the cuts necessaryto achieve the femur shape illustrated in FIG. 1 E. These grooves canenable the blade to access at a 90° angle to the surface of the exteriorportion, or, for example, at a 45° angle. Other angles are also possiblewithout departing from the scope of the invention.

As shown by the dashed lines, the grooves (2442-2450) of the secondportion 2440, overlay the apertures of the first layer.

FIG. 6 F illustrates a side view of the second, exterior, cutting blockportion 2440. From the side view a single aperture 2450 is provided toaccess the femur cut. FIG. 26 G is another side view of the second,exterior, portion 2440 showing the location and relative angles of therectangular grooves. As evidenced from this view, the orientation of thegrooves 2442, 2448 and 2450 is perpendicular to at least one surface ofthe second, exterior, portion 2440. The orientation of the grooves 2444,2446 is at an angle that is not perpendicular to at least one surface ofthe second, exterior portion 2440. These grooves (2444, 2446) facilitatemaking the angled chamfer cuts to the femur. FIG. 6 H is a top view ofthe second, exterior portion 2440. As will be appreciated by those ofskill in the art, the location and orientation of the grooves willchange depending upon the design of the femoral implant and the shaperequired of the femur to communicate with the implant.

FIG. 6 I illustrates a spacer 2401 for use between the first portion2410 and the second portion 2440. The spacer 2401 raises the secondportion relative to the first portion, thus raising the area at whichthe cut through groove 2424 is made relative to the surface of thefemur. As will be appreciated by those of skill in the art, more thanone spacer can be employed without departing from the scope of theinvention. Spacers can also be used for making the tibial cuts. Optionalgrooves or channels 2403 can be provided to accommodate, for example,pins 2460 shown in FIG. 6 J.

Similar to the designs discussed above with respect to FIG. 5,alternative designs can be used to control the movement and rotation ofthe cutting block 2440 relative to the mold 2410. As shown in FIG. 6 J aseries of protrusions, illustrated as pegs 2460, are provided thatextend from the superior surface of the mold. These pegs or protrusionscan be telescoping to facilitate the use of molds if necessary. As willbe appreciated by those of skill in the art, one or more pegs orprotrusions can be used without departing from the scope of theinvention. For purposes of illustration, two pegs have been shown inFIG. 6 J. Depending on the control desired, the pegs 2460 are configuredto fit within, for example, a curved slot that enables rotationaladjustment similar to the slots illustrated in FIG. 5 K or within arecess that conforms in shape to the peg, similar to that shown in FIG.5 L and described with respect to the tibial cutting system. As will beappreciated by those of skill in the art, the recess 2462 can be sizedto snugly encompass the peg or can be sized larger than the peg to allowlimited lateral and rotational movement.

As illustrated in FIG. 6 K the surface of the mold 2410 can beconfigured such that the upper surface forms a convex dome 2464 thatfits within a concave well 2466 provided on the interior surface of thecutting block 2440. This configuration enables greater rotationalmovement about the mechanical axis while limiting lateral movement ortranslation.

In installing an implant, first the tibial surface is cut using a tibialblock, such as those shown in FIG. 6. The patient specific mold isplaced on the femur. The knee is then placed in extension and spacers2401, such as those shown in FIG. 6 M, or shims are used, if required,until the joint optimal function is achieved in both extension andflexion. The spacers, or shims, are typically of an incremental size,e.g., 5 mm thick to provide increasing distance as the leg is placed inextension and flexion. A tensiometer can be used to assist in thisdetermination or can be incorporated into the mold or spacers in orderto provide optimal results. The design of tensiometers are known in theart and are not included herein to avoid obscuring the invention.Suitable designs include, for example, those described in U.S. Pat. No.5,630,820 to Todd issued May 20, 1997.

As illustrated in FIGS. 6 N (sagittal view) and 6 O (coronal view), theinterior surface 2413 of the mold 2410 can include small teeth 2465 orextensions that can help stabilize the mold against the cartilage 2466or subchondral bone 2467.

3D guidance templates may be used to create more that one cut on thesame and/or on the opposite articular surface or opposite articularbone, in accordance with an embodiment of the invention. These cuts maybe cross-referenced with other cuts using one or more guidancetemplate(s).

In accordance with one embodiment of the invention, the 3D guidancetemplate(s) are utilized to perform more than one cut on the samearticular side such as the femoral side of a knee joint. In anotherembodiment, a 3D guidance template may be utilized to cross referencesurgical interventions on an opposing articular surface. In a knee, forexample, the first articular surface can be the femoral surface. Theopposing articular surface can be the tibial surface or the patellasurface. In a hip, the first articular surface can be the acetabulum.The opposing articular surface or the opposing bone can be the proximalfemur.

Thus, in a knee, a horizontal femur cut can be cross-referenced with ananterior or posterior femur cut or optionally also chamfer, obliquecuts. Similarly, a tibial horizontal cut can be cross-referenced withany tibial oblique or vertical cuts on the same articular side orsurface.

In accordance with another embodiment, one or more femur cuts can becrossed-referenced with one or more tibial cuts. Or, in a hip, one ormore acetabular cuts or surgical interventions can be cross-referencedwith one or more femoral cuts or surgical interventions such asdrilling, reaming or boring. Similarly, in a knee again, one or morefemur cuts can be cross-referenced with one or more patella cuts. Anycombination and order is possible.

The cross-referencing can occur via attachments or linkages includingspacers or hinge or ratchet like devices from a first articular boneand/or cartilage surface, to a second articular, bone and/or cartilagesurface. The resulting positioning of the cut on the opposing articular,bone or cartilage surface can be optimized by testing the cut formultiple pose angles or joint positions such as flexion, extension,internal or external rotation, abduction or adduction. Thus, forexample, in a knee a distal femur cut can be performed with a mold. Viaa linkage or an attachment, a tibial template may be attached thereto orto the cut or other surgical intervention, thus a cross-reference can berelated from the femoral cut to a tibial cut or other surgicalintervention. Cross-referencing from a first articular surface to asecond articular surface via, without limitation, attachments orlinkages to a template has the advantage of insuring an optimalalignment between the implant or other therapeutic device components ofthe first articular surface to that on a second articular surface.Moreover, by cross-referencing surgical interventions on a firstarticular surface to a second articular surface, improved efficienciesand time savings can be obtained with the resulted surgical procedure.

Cross-referencing the first, the second and, optionally a third or morearticular surface, such as in a knee joint, may be performed with asingle linkage or attachment or multiple linkages or attachments. Asingle pose angle or position of a joint or multiple pose angles orpositions of a joint may be tested and optimized during the entiresurgical intervention. Moreover, any resulting surgical interventions onthe opposite, second articular surface, bone or cartilage may be furtheroptimized by optionally cross-referencing to additional measurementtools such as standard alignment guides.

For example, in a knee joint, a 3D template may be utilized to performone or more surgical interventions on the femoral side, such as afemoral cut. This can then be utilized via a linkage, an attachment orvia indirect cross-referencing directly onto the site of surgicalintervention, to guide a surgical intervention such as a cut of thetibial side. Prior to performing the surgical intervention on the tibialside, a traditional tibial alignment guide with cross-reference to themedial and lateral malleolus of the ankle turn may be used to optimizethe position, orientation and/or depth and extent of the plannedsurgical intervention such as the cut. For example, cross-referencing tothe femoral cut can aid in defining the relative superior inferiorheight of the tibial cut, while cross-referencing a tibial alignmentguide can optionally be utilized to determine the slant of the cut inthe interior posterior direction.

An exemplary system and methodology is now described in which a femoraltemplate is used to make a cut on the femur, which is thencross-referenced to properly align a tibial template for making a cut onthe tibial plateau. Initially, an electronic image(s) of the leg isobtained using imaging techniques elaborated in above-describedembodiments. For example, a pre-operative CT scan of a patient's leg maybe obtained to obtain electronic image data.

Image processing is then applied to the image data to derive, withoutlimitation, relevant joint surfaces, axis, and/or cut planes. Imageprocessing techniques may include, without limitation, segmentation andpropagation of point clouds.

Relevant biomechanical and/or anatomical axis data may be obtained byidentifying, for example, the central femoral head, central knee jointand center of the distal tibia. The cutting planes may then be definedbased on at least one of these axis. For example, the tibial implantbearing surface may be defined as being perpendicular to the axisdefined by the center of the tibial plateau 2496 and the center of thedistal tibia 2497, as illustrated in FIG. 6 P; the tibial implant'smedial margin may project towards the femoral head, as illustrated inFIG. 6 Q; and the anterior to posterior slope of the tibia may beapproximated by the natural anatomical slope (alternatively, excessivetibial slope may be corrected).

The tibial and femoral templates and implants may be designed based, atleast in part, on the derived joint surfaces, axis and/or cut planes.FIGS. 6 R and 6 S show isometric views of a femoral template 2470 and atibial template 2480, respectively, in accordance with an embodiment ofthe invention. The femoral template 2470 has an interior surface that,in various embodiments, conforms, or substantially conforms, with theanatomic surface (bone and/or cartilage) of the femur 2475. Furthermore,the interior surface of the femoral template may extend a desired amountaround the anatomical bony surfaces of the condyle to further ensureproper fixation. The interior surface of the tibial cutting block 2480may conform, or substantially conform to the surface (bone and/orcartilage) of the tibia 2481.

In an exemplary use, the femoral template 2470 is placed on the femoralcondyle 2475, for example, when the knee is flexed. The femoral template2470 may be fixed to the femoral condyle 2475 using, without limitation,anchoring screws/drill pins inserted through drill bushing holes 2471and 2472. The position of holes 2471 and 2472 on the condyle may be thesame used to anchor the final implant to the femur. In variousembodiments, the holes 2471 and 2472 may include metal inserts/bushingsto prevent degradation when drilling. Fixing the template 2470 to thefemoral condyle 2475 advantageously prevents movement of the templateduring subsequent cutting or other surgical interventions therebyensuring the accuracy of the resultant surgical cuts.

To assist in accurately positioning the femoral template 2470, a femoralguide reference tool 2473 may be attached to the femoral template 2470,as shown in FIG. 6 T. The femoral guide reference tool 2473 may, withoutlimitation, attach to one of holes 2471 and 2472. The femoral guidereference tool 2473 may reference off the tangential margin of theposterior condyle, and aid, for example, in correct anterior-posteriorpositioning of the femoral template 2470.

Upon proper fixation of the femoral template 2470 to the femoral condyle2475, a cut to the femoral condyle is made using cut guide surface orelement 2474. The cut guide surface or element 2474 may be integral tothe femoral template 2470, or may be an attachment to the femoraltemplate 2470, with the attachment made of a harder material than thefemoral template 2470. For example, the cut guide surface or element2474 may be a metal tab that slides onto the femoral template 2470,which may be made, without limitation, of a softer, plastic material.

Upon making the femoral cut and removing the femoral template 2475, asample implant template 2476 (not the final implant) is optionallypositioned on the condyle, as shown in FIG. 6 u, in accordance with anembodiment of the invention. The sample implant template 2474 may beattached to the condyle by using without limitation, anchoringscrews/drill pins inserted through the same holes used to anchor thefinal implant to the femur.

The sample implant template 2476 includes an attachment mechanism 2494for attaching the tibial template 2480, thereby cross-referencing theplacement of the distal tibial cut with respect to the femoralcut/implant's placement. The attachment mechanism 2494 may be, withoutlimitation, a boss, as shown in FIG. 6 U, or other attachment mechanismknown in the art, such as a snap-fit mechanism. Note that in alternativeembodiments, a sample implant template 2476 is not required. Forexample, the tibial template 2480 may attach directly to the femoraltemplate 2470. However, in the subject embodiment, the drill bushingfeatures of the femoral template 2475 will interfere with the knee goinginto extension, preventing the tibial cut.

In illustrative embodiments, the thickness of the sample implanttemplate 2476 may not only include the thickness of the final femoralimplant, but may include an additional thickness that corresponds to apreferred joint space between tibial and femoral implants. For example,the additional thickness may advantageously provide a desired jointspace identified for proper ligament balancing or for flexion,extension, rotation, abduction, adduction, anteversion, retroversion andother joint or bone positions and motion.

FIG. 6 V is an isometric view of the interior surface of the sampleimplant template 2476, in accordance with an embodiment of theinvention. In various embodiments, the femoral implant often rests onsubchondral bone, with the cartilage being excised. In embodiments wherethe sample implant template 2474 extends beyond the dimensions of thefemoral implant such that portions of the sample implant template 2476rests on cartilage, an offset 2477 in the interior surface of the sampleimplant template 2476 may be provided.

FIG. 6 W is an isometric view of the tibial template 2480 attached tothe sample implant 2476 when the knee is in extension, in accordancewith an embodiment of the invention. A crosspin 2478 inserted throughboss 2494 fixes the tibial template 2480 to the sample implant template2474. Of course, other attachment mechanisms may be used, as describedabove. In preferred embodiments, the tibial template 2480 may also befixed to the tibia 2481 using, without limitation, anchoringscrews/drill pins inserted through drill bushing hole 2479. In variousembodiments, the holes 2479 include metal inserts (or other hardmaterial) to prevent degradation when drilling. As with the femoraltemplate 2475, the cut guide surface or element of the tibial template2480 may be integral to the tibial template 2475, or may be anattachment to the tibial template 2480, the attachment made of a hardermaterial than the tibial template 2480. Upon fixing the position of thetibial template 2480, the cut guide of the tibial template 2475 assistsin guiding the desired cut on the tibia.

FIG. 6 X shows a tibial template 2490 that may be used, after the tibialcut has been made, to further guide surgical tools in forming anchoringapertures in the tibia for utilization by the tibial implant (e.g., thetibial implant may include pegs and/or keels that are used to anchor thetibial implant into the tibia), in accordance with an embodiment of theinvention. The outer perimeter of a portion of the tibial template 2490may mimic the perimeter of the tibial implant. Guide apertures in thetibial template 2490 correspond to the tibial implants fixationfeatures. A portion of the tibial template 2490 conforms to, withoutlimitation, the anterior surface of the tibia to facilitate positioningand anchoring of the template 2490.

FIG. 6 Y shows a tibial implant 2425 and femoral implant 2426 insertedonto the tibia and femur, respectively, after the above-described cutshave been made, in accordance with an embodiment of the invention.

Thus, the tibial template 2480 used on the tibia can be cross-referencedto the femoral template 2476, femoral cut and/or sample implant 2474.Similarly, in the hip, femoral templates can be placed in reference toan acetabular mold or vice versa. In general, when two or more articularsurfaces will be repaired or replaced, a template can be placed on oneor more of them and surgical procedures including cutting, drilling,sawing or rasping can be performed on the other surface or othersurfaces in reference to said first surface(s).

An alternative embodiment of a knee implant, system and method ispresented herein below. In this embodiment, a library ofpatient-specific femoral spacing templates are utilized to provideaccurate and anatomically-correct ligament balancing, andpatient-specific templates, including an alignment tool for placing thevertical cut for the medial edge of the tibial component on tibialplateau, provide precise positioning of the femoral and tibial implants.In a procedure for installing an implant, the joint surfaces are firstprepared to receive the templates and the implants. A line may desirablydrawn on the femoral end, using, e.g., a marker or electrosurgicalpencil, to mark the anterior sulcus. Thereafter, soft tissue cartilageis desirably removed from the anterior sulcus, e.g., using a curvedelevator/osteotome, and posterior cartilage is removed also, e.g., usinga, e.g., 10 mm blade. Anterior cartilage removal is desirably started inthis procedure a small distance, e.g., 1 or 2 mm, below the sulcus line.Cartilage removal may be completed using, e.g., a 5 mm ringed/opencurette.

Next, the knee is placed into extension and patient-specific femoralbalancing templates are used to properly balance the ligaments in theknee, and in so doing determine the correct locations for the femoraland tibial components. The design (e.g., surface contours, outergeometry) of the femoral balancing templates is desirably derived frompatient-specific data, e.g., a CT image of the joint in question.Desirably a plurality of femoral balancing templates, each with acharacteristically larger thickness, is provided to enable convenientbut accurate ligament balancing. A greater number of femoral balancingtemplates (i.e., smaller incremental thickness from one template to thenext) provides more control over ligament balancing, but fewer femoralbalancing templates may be sufficient and also will have the advantageof a less-complex tool set for the surgeon to deal with. Arepresentation of a femoral balancing template 5101 on a femur,featuring split lug 5102, and through-holes 5103 and 5104, is depictedin FIG. 7. The design of the femoral balancing template may desirablymimic that of the permanent femoral implant.

The surgeon determines the appropriate femoral balancing template toachieve the desired ligament tensioning in extension, from the choicesat hand, and the template is placed on the condylar surface for which itis intended, while the knee is in flexion. Once the femoral balancingtemplate is securely placed in its intended location on the condylarsurface (which may include bone and/or cartilage), the knee is placedinto extension. Some cartilage may be removed from the tibia if the fitin extension is too tight. FIG. 8 shows a view of a knee in balancedextension with femoral balancing template 5101 fitted on femoral condyle5201 and between femoral condyle 5201 and tibial plateau 5202.

Once the knee has been balanced in extension, a tibial cutting guide5301, having an interface surface 5302 which conforms to an anteriorsurface of the tibia 5303, is fitted to the tibia, as shown in FIG. 9.Interface surface 5302 is desirably derived from patient-specific data.Locking arm 5304 is designed to fit tab 5305 into the slot of split lug5102. Horizontal cutting guide 5306 and stop 5310 are provided to enablethe horizontal cut for the tibial implant, and pin holes 5307 and 5308are provided so guide 5301 may be secured to the anterior tibial face.Tab 5305 is fitted into the slot of split lug 5102, and secured tofemoral balancing template 5101 with cross-pin 5309. A tibial alignmentguide (not shown) may be desirably attached to the tibial cutting guideat this point in time to confirm slope (tibial axial alignment). Such atibial alignment guide comprises an ankle clamping means at one end ofthe alignment guide, distal to the knee; a rod attached to and spanningfrom the ankle clamping means to the tibial cutting guide; andattachment means to attach the rod to the tibial cutting guide.

Once proper alignment of tibial cutting guide 5301 is confirmed, drillholes are made through pin holes 5307 and 5308, and the guide is pinnedin place by inserting pins 5401 and 5402 into the drill holes, as seenin FIGS. 10 and 11.

Next, the horizontal tibial cut for the tibial implant is made.Cross-pin 5309 is removed, the knee is brought into flexion, and femoralbalancing template 5101 is removed, as depicted in FIG. 12. The coronaltibial cut is made by guiding oscillating saw blade 5701 (FIG. 13)against horizontal cutting guide 5306; stop 5310 keeps the horizontalcut from proceeding past the desired end. Once the horizontal cut ismade, the tibial cutting guide is removed.

FIGS. 14 and 15 illustrate the use of a patient-specific cut alignmenttool 5801 (also referred to herein as a navigation chip) to preciselyplace, without limitation, at least one of a vertical tibial cut or ahorizontal tibial cut. Tool 5801 may have a straight medial edge 5802that may correspond to the line where the vertical cut for the tibialimplant is to be placed, and patient-specific surface 5803 that is amirror image of the tibial surface (which may include bone and/orcartilage) to which it is to mate. The patient-specific surface 5803 maybe substantially a mirror image of the articular of the articularcartilage, including normal or diseased cartilage, the subchondral bone,or, optionally, exposed endosteal bone or bone marrow, or combinationsthereof. In other words, when surface 5803 is fitted to the tibialplateau, the desired location for the vertical cut, and, by extension,the external edge of the tibial implant, is precisely determined. Forexample, in a medial unicompartmental implant, the external edge caninclude the medial aspect of the tibial cortical bone. In a lateralunicompartmental implant, the external edge can include the lateralaspect of the tibial cortical bone. In various embodiments, thepatient-specific cut alignment tool 5801 may conform to a weight bearingsurface, a non-weight bearing surface, and/or an anatomical landmark. Infurther embodiments, the patient patient-specific cut alignment tool5801 may have a periphery or an outer edge that matches the rim or outerperiphery of the surface it contacts (e.g., the outer periphery of thetibial plateau), allowing, for example, further visual confirmation ofproper alignment. In still further embodiments, the tibial cut alignmenttools disclosed herein have the benefit of ensuring that the outer edgeof the tibial implant to does not overhang or underhang the cut edge ofthe tibial plateau. In still further embodiments the patient specificalignment tools can rest on the articular surface, but can also extendto or include cortical bone and can even rest against soft-tissueincluding ligamentous structures.

In various embodiments, the top surface of the alignment tool 5801 maybe flat, convex, or concave or combinations thereof. The top surface maybe, at least in part, patient matched to the tibia or the femur. Forexample, the top surface may be, at least in part, a copy or near copyof the tibial surface. Alternatively, the top surface of the alignmenttool may be, at least in part, a mirror image of one or more femoralcondyles. In all of these embodiments, the top surface of the tibialalignment tool 5801 may be derived from the articular cartilage,including normal or diseased cartilage, the subchondral bone, or,optionally, exposed endosteal bone or bone marrow, or combinationsthereof.

In another embodiment, the top surface of the alignment tool 5801 may bea mirror image of, at least in part, a femoral implant bearing surface.The femoral implant bearing surface can be a standard (off-the-shelf)bearing surface or can be patient individualized, e.g. to the patient'sbone or cartilage or combinations thereof. The top surface of thealignment tool 5801 may be a mirror image to, at least in part, afemoral implant bearing surface in at least one of a coronal plane, asagittal plane, or combinations thereof,

Before the alignment tool 5801 is placed on the plateau of FIGS. 14 and15, cartilage may be optionally removed from the plateau, e.g., theanterior two thirds of the tibia. The alignment tool 5801 is placed onthe plateau, and a vertical cut is made as illustrated in FIG. 15.Alternatively, the tool 5801 may be kept in place, a line made alongedge 5802 with an electrosurgical pencil, and the cut may be made alongthe pencil line with the tool 5801 removed. The profile of the tibialcut may be confirmed using a spacer block as described below.

In still other embodiments, the patient-specific cut alignment tool 5801may be used to simply visually confirm the location of a cut, withanother cut guide used to actually direct the surgical instrument inmaking the cut. FIG. 29 shows a tibial cut guide pinned in extension, inaccordance with one embodiment of the invention. FIG. 30 shows thefemoral balancing template removed, the patient specific alignment tool5801 positioned on the tibial plateau, and a cutting guide attached tothe tibia. The cutting guide may be used to make both the horizontal andvertical cuts on the tibial plateau, in accordance with one embodimentof the invention. In FIG. 29, the cutting guide is secured to the tibiausing, in part, an optional pin hole or a linkage or joint that isshaped so as to allow limited or direct movement of the cutting guidewhen the femoral balancing template is removed. The patient-specific cutalignment tool 5801 is used to confirm the location of the cut, and theposition of the cutting guide is adjusted to align with the confirmedlocation. Once in the proper position, the cutting guide can be fixed inposition via another pin/pin hole, as shown in FIG. 29, and the cut canbe made.

In yet other embodiments, the patient-specific cut alignment tool 5801may be used to properly balance the ligaments in the knee, with orwithout, for example, the use of the femoral balancing template(s). Aplurality of patient-specific cut alignment tools 5801 may be provided,each with a characteristically larger thickness. The top surface of thepatient-specific cut alignment tools 5801 may be flat to allow foreasier balancing. It may also have a slight curvature to it, which maybe convex or concave. Various chips may be inserted, with a chipselected that provides the desired ligament tensioning. For example,each chip may be inserted in turn from, without limitation, thinnest tothickest with the knee in flexion or extension and then taken throughthe desired range of motion. The anatomic shape of the balancer allowsfor simplified balancing without the typical complexity of mostbalancing procedures.

Thus, the patient-specific alignment tool 5801 may fulfill multiplefunctions: It may be used for guiding a vertical tibial cut, if apartial tibial replacement is contemplated. It may be used forreferencing a horizontal tibial cut, when a partial or total knee systemis contemplated. In this case, it may be combined it with spacer blocksor femoral balancing tools. It may be used for ligament balancing.Moreover, the patient specific alignment tool 5801 may be made availablein various thicknesses, e.g. 1, 2, 3 or 4 mm for testing ligamenttension in at least one of flexion or extension or combinations thereoffor achieving optimal ligament balancing or soft-tissue or ligamenttensioning. The thickness of the balancing chip that is inserted willdetermine the level at which the horizontal tibial cut is made. Forexample, with a thicker balancing or navigation chip, the tibial cutwill be more superior, i.e. more tibial bone is preserved. With athinner navigation chip, the tibial cut will be more inferior, i.e. moretibial bone is resected.

In various embodiments, the tibial cut guide may connect to, a selectedpatient-specific cut alignment tool 5801, which may be applied to one orboth articular sides, instead of, or in addition to, the femoralbalancing template 5101. For example, a tibial cut guide may include,without limitation, a dovetail feature or other linkage or joint thatslides into the patient-specific cut alignment tool 5801. Otherinterface/connector means known in the art may be used, such as, withoutlimitation, a snap-fit, joints, and/or cross-pins. Any linkage known inthe art may be utilized. Some of these joints or linkages may allow formovement or adjustment in one or more directions. The connection betweenthe patient-specific cut alignment tool 5801 and a tibial cut guide maybe made at a set distance from, for example, the top of each of thepatient-specific cut alignment tools 5801. Subsequently, the thicker thepatient-specific cut alignment tool 5801, the less bone is resected offthe tibia. The tibial cutting guide may be used to make either or boththe horizontal and vertical cuts on the tibial plateau. Thus, thepatient specific alignment tool is used to not only determine thelocation and orientation of the vertical cut, but also the location andheight of the horizontal cut. The thickness of the selectedpatient-specific cut alignment tool 5801, combined with the set positionof the connected tibial cut guide relative to the patient-specific cutalignment tool 5801, correctly positions the horizontal cut on the tibiawith regard to ligament balancing or ligament tension or soft-tissuetension, taking into account the thickness of the femoral and/or tibialimplants to be inserted.

In illustrative embodiments, the interface between the patient-specificcut alignment tool 5801 and the tibial cut guide may impart a desiredslope on the cut guide. For example, the top surface of thepatient-specific cut alignment tool 5801 to which the tibial cut guidemay dovetail into, may be sloped (with the slope determined via patientspecific information), such that, without limitation, the tibial surfaceis resected perpendicular to the long axis of the tibia in the coronalplane, but sloped posteriorly in the sagittal plane to match the normalslope of the tibia. The slope may be imposed by the patient specific cutalignment tool 5801, with the slope transferred into the cut guide via alinkage. The slope may also be set in the tibial cut guide based onpatient specific information included in and/or derived from the patientspecific cut alignment tool 5801. For example, the slope of the tibialcut guide may be adjustable based on the configuration or otherinformation associated with the patient specific cut alignment tool5801. The patient specific information can be derived from apreoperative scan or an intraoperative measurement. It will typically bethe slope that the patient's tibia showed on the preoperative scan. Thescan may be of the same joint or a contra lateral healthy joint. Anoffset or a threshold may be applied. For example, if theanteroposterior slope in a patient exceeds 7 mm, the maximum allowablevalue of slope determined by the patient specific alignment tool may beset at 7 mm, i.e. the selected maximum. The maximum can optionally bederived as a function of the measured slope in that patient. If apatient has a preoperative tibial slope of less than 7 degrees, e.g. 4degrees, the tibial slope in the patient specific alignment tool may beset at a number corresponding to the measured slope, i.e. in thisexample 4 degrees. Thus, the patient specific alignment tool may notonly yield a reference for the orientation of the vertical cut andoptionally horizontal cuts of a tibia, but also on the anteroposteriorslope desirable in a patient. If a patient has a preoperative tibialslope of greater than 7 degrees, 7 degrees may be set as the maximum andthe horizontal tibial cut may be made at a slope of 7 degrees. Otherthresholds may be used, e.g. 6 degrees, 8 degrees, etc.

All of the embodiments pertaining to the balancing chip and all otherembodiments may be applied to partial knee systems, e.g. medial orlateral unicompartmental tibiofemoral implants, as well as to total kneearthroplasty systems.

The embodiments may be used in the context of a femur first technique,i.e. the femur is prepared prior to preparing the tibia, or a tibiafirst technique, i.e. the tibia is prepared prior to preparing thefemur, or combinations thereof. For example, the alignment tool 5801 maybe used initially to balance the joint and to place a horizontal tibialcut, while then moving to the femoral preparation, and finishing thetibia at the end.

All of the embodiments pertaining to the balancing chip and all otherembodiments may be applied to a knee joint, but also any other joint inthe body. The terms “femur” or “femoral” and “tibia” and “tibial” arestrictly illustrative and can also represent other bone or jointgeometries. For example, the embodiments and the navigation chip can beapplied in a hip (in which case the terms “tibia” and “tibial” can bereplaced with “acetabulum” and “acetabular”, and “femur” and “femoral”can be replaced with “femoral head” and “femoral”). The embodiments maybe applied in a shoulder (in which case the terms “tibia” and “tibial”can be replaced with “glenoid” and “glenoid”, and “femur” and “femoral”can be replaced with “humeral head” and “humeral”). The same analogiesapply to other joints including the elbow, wrist, ankle, foot and hand.

All of the embodiments pertaining to the balancing chip and all otherembodiments may be applied to hemiarthroplasty.

All of the embodiments pertaining to the balancing chip and all otherembodiments may be used in combination with surgical navigation orrobotic surgery. For example, radiofrequency and optical markers may beused for planning femoral and tibial bone cuts, while a balancing chipas described above may be used for ligament balancing or soft-tissue orligament tensioning. The markers may optionally be connected, directlyor via a linkage, to the balancing chip. Moreover, in another example, arobot may be used for planning or directing tibial or femoral bone cuts,while a balancing chip as described above may be used for ligamentbalancing or soft-tissue or ligament tensioning. The robot mayoptionally be connected, directly or via a linkage, to the balancingchip or to any other patient specific alignment tool.

FIGS. 16-23 illustrate the procedure and tools for installing thefemoral implant of this embodiment. FIG. 16 illustrates femoral guide6001 and removable L guide 6002 which has a short pin which fits intolower pin hole 6004, and around which L guide 6002 may rotate foralignment purposes. The knee is placed into flexion. Guides 6001 and6002 are assembled, and patient-specific surface 6005 is mated to thefemoral surface. Spacer block 6010, which has a patient-specific outeredge, i.e., the horizontal geometry replicates the area of the cuttibial plateau, is placed onto the cut tibial surface 6002. Spacer block6010 may be provided in a number of thicknesses to ensure proper spacingwith the knee in flexion. L guide 6002 is adjusted to sit flat on spacerblock with knee in flexion (FIG. 18), adjusting the flexion angle ifnecessary to facilitate this. A drill hole in the femur is made throughpin hole 6003 (FIG. 19), and a pin 6401 is inserted to fix guide 6001 tothe femur (FIG. 20). L guide 6002 is removed, and a drill hole in thefemur is made through pin hole 6004 (FIG. 21), and a pin 6601 isinserted in pin hole 6004 of guide 6001 (FIG. 22).

With the femoral guide 6001 thus pinned to the femur, a posteriorfemoral cut in preparation for receiving a femoral implant is made;oscillating saw blade 6701 is moved against horizontal cutting guide6702 to remove bone in the posterior portion of the condyle (FIG. 22.)The femoral guide 6001 is removed, and a trough for the anterior marginof the femoral implant is made.

FIGS. 24-27 illustrate a procedure and tools for installing the tibialimplant of this embodiment, wherein patient-specific template 6901,having drill holes 6902 and 6903 is placed in the cut tibial area, holesare drilled, and pins 7302 and 7301 are inserted to fix the template inplace. In FIG. 28, a fin is created using an osteotome (e.g., about 5 mmin width), using guide slot 7303. Template 6901 can then be removed towiden and finish the fin hole preparation. The implants may now beinstalled.

In illustrative embodiments, three-dimensional guidance templates may beutilized to determine an optimized implant rotation. Examples areprovided below with reference to the knee, however it is to beunderstood that optimizing implant rotation may be applied to otherjoints as well.

Femoral Rotation:

The optimal rotation of a femoral component or femoral implant for auni-compartmental, patello femoral replacement or total knee replacementmay be ascertained in a number of different ways. Implant rotation istypically defined using various anatomic axes or planes. These anatomicaxes may include, without limitation, the transepicondylar axis; theWhiteside line, i.e. the trochlea anteroposterior axis, which istypically perpendicular to at least one of the cuts; and/or theposterior condylar axis. Other axes include but are not limited toBlumensaat's line, femoral shaft axis, femoral neck axis, acetabularangle, lines tangent to the superior and inferior acetabular margin,lines tangent to the anterior or posterior acetabular margin, femoralshaft axis, tibial shaft axis, transmalleolar axis, posterior condylarline, tangent(s) to the trochlea of the knee joint, tangents to themedial or lateral patellar facet, lines tangent or perpendicular to themedial and lateral posterior condyles, lines tangent or perpendicular tocentral weight-bearing zone of the medial and lateral femoral condyles,lines transsecting the medial and lateral posterior condyles, forexample through their respective centerpoints, lines tangent orperpendicular to the tibial tuberosity, lines vertical or at an angle toany of said lines, lines tangent to or intersecting the cortical bone ofany bone adjacent to or enclosed in a joint.

Another approach for optimizing femoral component rotation is aso-called balancing gap technique. With the balancing gap technique, afemoral cut is made parallel to the tibia, i.e. the tibia is cut firsttypically. Prior to performing the femoral cut, the femoral cut plate isoptimized so that the medial and lateral ligament and soft tissuetension are approximately equal.

By measuring the relevant anatomic axis or planes, the optimal implantrotation may be determined. The measurement may be factored into theshape, position or orientation of the 3D guidance template, inaccordance with an embodiment of the invention. Any resultant surgicalinterventions including cuts, drilling, or sawings are then madeincorporating this measurement, thereby achieving an optimal femoralcomponent rotation.

Moreover in order to achieve an optimal balancing, the rotation of thetemplate may be changed so that the cuts are parallel to the tibial cutwith substantially equal tension medially and laterally applied.

Tibial Rotation:

A 3D guidance template may also be utilized to optimize tibial componentrotation for uni-compartmental or total knee replacements, in accordancewith an embodiment of the invention. Tibial component rotation may bemeasured using a number of different approaches known in the art. In oneexample of a tibial component rotation measurement, the anteroposterioraxis of the tibia is determined. For a total knee replacement, thetibial component can be placed so that the axis of the implant coincideswith the medial one-third of the tibial tuberosity. This approach canwork well when the tibia is symmetrical.

In another embodiment, the symmetrical tibial component is placed as faras possible posterolateral and externally rotated so that theposteromedial corner of the tibial plateau is uncovered to an extent ofbetween three (3) and five (5) millimeters.

The above examples are only representative of the different approachesthat have been developed in the literature. Clearly, other variousanatomic, biomechanical axis, plane and area measurements may beperformed in order to optimize implant rotation.

In illustrative embodiments, these measurements may be factored into thedesign of a 3D guidance template and the position, shape or orientationof the 3D guidance template may be optimized utilizing this information.Thus, any subsequent surgical intervention such as cutting, sawingand/or drilling will result in an optimized implant rotation, forexample, in the horizontal or in a near horizontal plane.

Example 1 below is included to more fully illustrate the presentinvention. Additionally, this example provides a single embodiment ofthe invention and is not meant to limit the scope thereof.

Example 1 Unicompartmental Knee Resurfacing Using Patient-SpecificImplants and Instrumentation

An exemplary surgical technique for use in implanting a novel partialknee resurfacing UKA using customized, single-use instrumentation isdescribed below, in accordance with one embodiment of the invention.

CT scans of a patient's knee and partial scans of the hip and ankle areutilized to create patient-specific implants and instrumentation. Basedon the CT images, the knee anatomy is digitally recreated, the surfacetopography of the femur and tibia are mapped, and axis deformity iscorrected. The same data is used to create cutting and placement guidesthat are pre-sized and pre-navigated to work with the patient's anatomyand custom implants.

A kit may be provided with the resurfacing implants and disposableinstrumentation in a single sterile tray, as shown in FIG. 31, inaccordance with one embodiment of the invention. The various instrumentsin the kit may be patient-specific instruments or non-patient specificinstruments, for example, standardized tools, templates and otherdevices that may be used during the course of the surgery and inconjunction with other patient-specific instruments and other devices.

The surgical technique may illustratively include the following steps,described in more detail below: patient positioning and preparation;balancing of the knee; axial & sagittal tibial cuts; femoralpreparation; balancing verification & tibial preparation; and trialing &cementing of implant.

Patient Positioning and Preparation

The patient is positioned supine on the table with the leg resting on afoot support around 90 degrees flexion. After a standard short midlineskin incision, a medial or lateral parapatellar arthrotomy is performed.The medial (or lateral) sleeve is not released, but typically allfemoral and tibial osteophytes, including those in the intercondylarnotch are removed.

In extension the sulcus terminalis is marked with a marking pen, wherethe anterior tibial lip hits the femoral condyle. The femoral cuttingblock, which is shaped to substantially fit the condyle and representsthe size and geometry of the femoral implant is placed on the femoralcondyle. Typically, the anterior edge of the femoral cutting block seatsabout 2-3 mm inferior to the Sulcus terminalis. The round anteriorsilhouette of the femoral cutting block is marked on the femoralcondyle.

The implant is typically designed to the surface of the subchondral bonewith a thickness of 3.5 mm. Since it resurfaces the bone plate,substantially all cartilage posterior to the sulcus terminalis,including the posterior condyle, is removed. This may be facilitated,for example, using a 10 millimeter blade, curved elevator, osteotome ora ring-currette, as shown in FIGS. 32 and 33, in accordance with oneembodiment of the invention. That the femoral jig conforms to thecondyle after cartilage removal is then confirmed.

Once removal of all residual cartilage on the femur has been concluded,residual cartilage is scraped off the tibial plateau and balancing ofthe knee is started.

Balancing of the Knee

Four navigation “chips” of varying thicknesses in 1 mm increasingincrements are included in the instrument tray. Each chip has anunderside that substantially matches the shape and topography of thepatient's tibial surface. When inserted into the compartment, the chipwill self-seat into a stable position due to its conformity with theanatomic landmarks on the tibia. The top surface of this chip is flat toallow referencing off the distal femor condylar surface duringbalancing. FIG. 34 shows an exemplary navigation chip, in accordancewith one embodiment of the invention.

Each chip may be inserted in turn, from thinnest to thickest, with theknee in flexion and then taken through the desired range of motion. Achip is then selected that provides the desired ligament tensioning.FIG. 35 shows a navigation chip in-situ, in accordance with oneembodiment of the invention.

Illustratively, an opening under valgus stress of about 1 mm isrecommended medially in extension and 90 degrees flexion and about 1-3mm under varus stress laterally in extension and about 3-5 mm in 90degrees flexion. The thicker the chip, the less bone is resected off thetibia.

Axial & Sagittal Tibial Cuts

The selected navigation chip connects to a tibial cutting block (alsoreferred herein as the tibial jig). The tibial jig may also optionallyconnect to an extramedullary alignment guide. The alignment guide may beplaced on the leg and the tibial jig is attached to the navigation chipto establish its placement. The tibial jig may then be pinned flush tothe anterior tibia. FIG. 36 shows the tibial jig placed in the knee, inaccordance with one embodiment of the invention.

The tibial cut planes are confirmed with the navigation chip, as shownin FIG. 37, in accordance with one embodiment of the invention: thesagittal cut, the axial cut—90 degrees relative to the tibial mechanicalaxis—and the posterior slope. The tibial cutting block may berepositioned if necessary, whereupon the tibial cutting block is pinnedin place.

The sagittal tibial cut is performed using the tibial cutting block. Thereciprocating saw blade may be left in as shown in FIG. 34 to protectthe ACL while performing the axial cut. The axial tibial cut isperformed referencing off the tibial jig. FIG. 38 shows the tibial axialcut, in accordance with one embodiment of the invention. The AlignmentGuide and the Tibial Jig may then be removed.

Femoral Preparation

The femoral jig is placed on the distal femur and its position isverified. The femoral jig is designed to conform to the femur in onlyone location so as to aid in proper positioning. FIG. 39 shows thefemoral jig placed on the distal femur, in accordance with oneembodiment of the invention. Any additional cartilage or osteophytesthat were missed previously are removed until the fit is snug andsecure. Illustratively, the peg-holes may be drilled in 15 degreesflexion relative to the sagittal anatomical femoral axis and the amountto be removed off the posterior condyle may be 3-5 mm.

The femoral jig is then drilled and pinned in place and the posteriorfemoral cut is performed, as shown in FIG. 40 in accordance with oneembodiment of the invention. In various embodiments, this is the onlybone resection required on the femur.

To complete femoral preparation, an anterior recess may be preparedusing a curved osteotome or a 5 mm burr. Illustratively, the mostanterior edge of the component submerges 3.5 mm below the subchondralbone plate. The taper starts 10 mm inferior to it. Also the transitionfrom the subchondral bone to the anterior edge of the posterior cut maybe rounded, using either a file, burr or osteotome. Smoothening of theedge and placement and depth of recess may then be verified with afemoral trial implant.

Balancing Verification & Tibial Preparation

With the femoral trial implant in place, a spacer block is inserted,such as an 8 mm spacer block, and balance in flexion and extension isevaluated. FIG. 41 shows flexion and extension balance verification, inaccordance with one embodiment of the invention. If the knee is tootight, an additional 1 to 2 millimeters may be resected from the tibia.If too loose, the 10 millimeter spacer block may be inserted, withbalance in flexion and extension reevaluated.

The Tibial Template is placed on the tibia and both holes are drilled,pinning the anterior hole only to accommodate instruments for theupcoming fin hole preparation. FIG. 42 shows tibial template placement,in accordance with one embodiment of the invention. Next, the fin holeis created using, for example, a 5 millimeter osteotome. The tibialimplant is designed to match the patient anatomy and should cover thetibia cortex without overhang or undercoverage. The outline of thetibial template provides visual confirmation of the match.

Trialing & Cementing of Implant

Multiple 1.5 to 2 mm cement holes may be drilled to enhance cementinterdigitation with the femoral cortical surface, and the joint isthoroughly irrigated. FIG. 43 shows the femoral cement holes, inaccordance with one embodiment of the invention. Next, the metalimplants are placed into position and the trial poly is inserted whichprovides optimal balancing. Illustratively, two different thicknessesmay be provided, 6 mm or 8 mm. Combined with the 2 millimeter thicknessof the tibial tray, the 6 and 8 mm trials will correspond to the 8 and10 millimeter Spacer Blocks used to confirm proper balance.

The tibial tray may be cemented first, with all extruded cement removedand then the femoral component may be inserted. FIG. 44 shows theimplants being cemented, in accordance with one embodiment of theinvention. The knee is brought in 45 degrees and the trial tibial insertis inserted, allowing equal pressurization of the femoral component inflexion and in extension. All extruded cement is removed and the cementis allowed to harden. FIG. 45 shows the implants cemented in place, inaccordance with one embodiment of the invention. The trial insert isremoved along with any residual extruded cement and the realpolyethylene insert is inserted. Wound closure of the arthrotomy isrecommended in flexion and multiple layers.

The foregoing description of embodiments of the present invention hasbeen provided for the purposes of illustration and description. It isnot intended to be exhaustive or to limit the invention to the preciseforms disclosed. Many modifications and variations will be apparent tothe practitioner skilled in the art. The embodiments were chosen anddescribed in order to best explain the principles of the invention andits practical application, thereby enabling others skilled in the art tounderstand the invention and the various embodiments and with variousmodifications that are suited to the particular use contemplated. It isintended that the scope of the invention be defined by the followingclaims equivalents thereof

1. A system for articular repair, the system comprising: a firsttemplate having a first surface and a second surface, the first surfaceconforming with, and substantially a negative of, at least a portion ofa first side of a joint; a second template having a third surface thatconforms with, and is substantially a negative of, a portion of thefirst side of the joint, the second template including at least oneguide for guiding a surgical instrument in making a cut on the firstside of the joint; and an attachment mechanism for attaching the secondtemplate to the first template.
 2. The system according to claim 1,wherein the first or second template includes a guide for making avertical cut.
 3. The system according to claim 1, wherein the secondsurface is at least one of substantially flat, substantially concave,substantially convex, and matched to one of the first or second sides ofthe joint.
 4. The system according to claim 1, further comprising atleast one other template having a first surface and a second surface,the first surface of the at least one other template conforming with,and substantially a negative of, the at least a portion of the firstside of the joint, each of the other templates capable of attaching tothe second template, wherein the first template and each of the othertemplates vary in thickness.
 5. The system according to claim 1, whereinat least a portion of the first surface substantially conforms to atleast one of uncut subchondral bone, uncut cartilage, and uncut bone ofa first or second side of the joint.
 6. The system according to claim 1,wherein at least a portion of the second surface substantially conformsto at least one of uncut subchondral bone, uncut cartilage, and uncutbone of a first or second side of a joint.
 7. The system according toclaim 1, wherein at least a portion of the third surface substantiallyconforms to at least one of uncut subchondral bone, uncut cartilage, anduncut bone of a first or second side of a joint.
 8. The system accordingto claim 1, wherein the attachment mechanism includes at least one of asnapfit, dovetail and a cross-pin.
 9. The system according to claim 1,wherein the attachment mechanism allows for rotation relative to one ofan anatomical and a biomechanical axis.
 10. The system according toclaim 1, wherein the joint is at least one of a hip, knee, ankle, toejoint, shoulder, elbow, wrist, finger joint, spine or spinal joint. 11.A system for articular joint repair, the system comprising: a firsttemplate having a first surface and a second surface, the first surfacesubstantially a negative of at least a portion of the tibial plateau; asecond template having a third surface that is substantially a negativeof a portion of the tibia, the second template including at least oneguide for guiding a surgical instrument in making a cut on the tibia;and an attachment mechanism for attaching the second template to thefirst template.
 12. The system according to claim 11, wherein the firstor second template includes a guide for making a vertical tibial cut.13. The system according to claim 11, wherein the second surface is atleast one of substantially flat, substantially concave, substantiallyconvex, and matched to one of the tibia and the femur.
 14. The systemaccording to claim 11, further comprising at least one other templatehaving a first surface and a second surface, the first surface of the atleast one other template conforming with, and substantially a negativeof, the at least a portion of the tibial plateau, each of the othertemplates capable of attaching to the second template, wherein the firsttemplate and each of the other templates vary in thickness.
 15. Thesystem according to claim 11, wherein at least a portion of the firstsurface substantially is a negative of at least one of uncut subchondralbone, uncut cartilage, and uncut bone of a tibia.
 16. The systemaccording to claim 11, wherein at least a portion of the second surfacesubstantially is a negative of at least one of uncut subchondral bone,uncut cartilage, and uncut bone of a tibia.
 17. The system according toclaim 11, wherein at least a portion of the third surface substantiallyis a negative of at least one of uncut subchondral bone, uncutcartilage, and uncut bone of a tibia.
 18. The system according to claim11, wherein the attachment mechanism includes at least one of a snapfit,dovetail and a cross-pin.
 19. The system according to claim 11, whereinthe attachment mechanism allows for rotation relative to one of ananatomical and a biomechanical axis.
 20. The system according to claim11, wherein the at least one guide guides a surgical instrument inmaking a cut on the tibia having a desired slope relative to at leastone of a biomechanical and an anatomical axis.
 21. The system accordingto claim 11, wherein the articular joint repair is a joint resurfacing.22. The system according to claim 11, wherein the joint resurfacing is aknee joint resurfacing.
 23. The system according to claim 11, whereinthe articular joint repair is a joint replacement.
 24. A system forarticular repair, the system comprising: a first template having a firstsurface and a second surface, the first surface substantially matchingat least a portion of the tibial plateau, the first template including amedial edge that corresponds to a predetermined location for a verticaltibial cut.
 25. The system according to claim 24, further comprising asecond template having a third surface substantially matching at least aportion of the tibia, the second template including at least one guidefor guiding a surgical instrument; and an attachment mechanism forattaching the second template to the first template.
 26. The systemaccording to claim 25, wherein the first template includes a guide forguiding a surgical instrument.
 27. The system according to claim 25,wherein the medial edge is adapted as a guide for making a verticaltibial cut.
 28. The system according to claim 25, further comprising atleast one other template having a first surface and a second surface,the first surface of the at least one other template substantiallymatching at least a portion of the tibial plateau, wherein the firsttemplate and each of the other templates vary in thickness.
 29. Thesystem according to claim 24, wherein at least a portion of the firstsurface substantially matches at least one of uncut subchondral bone,uncut cartilage, and uncut bone.
 30. A kit for testing at least one ofligament balancing and ligament tension, the kit comprising: a firsttemplate having at least one surface substantially conforming with atleast a portion of a first articular joint surface; wherein the templateis configured for placement on the first articular joint surface andbetween the first articular joint surface and a second articular jointsurface, the template having a predefined thickness configured toprovide a physical spacer for assessing at least one of ligament balanceand ligament tension during a surgical procedure.
 31. The kit of claim30, further comprising: a second template having at least one surfacesubstantially conforming with at least the portion of the firstarticular joint surface; wherein the template is configured forplacement on the first articular joint surface and between the firstarticular joint surface and the second articular joint surface, thetemplate having a second predefined thickness configured to provide aphysical spacer for assessing at least one of ligament balance andligament tension during a surgical procedure.
 32. The kit of claim 30,further comprising: at least two additional templates each having atleast one surface substantially conforming with at least a portion ofthe first articular joint surface; wherein each template is configuredfor placement on the first articular joint surface and between the firstarticular joint surface and the second articular joint surface, thetemplates having unique thicknesses configured to provide a set ofspacers of different thicknesses for assessing at least one of ligamentbalance and ligament tension during a surgical procedure.
 33. The kitaccording to claim 30, further comprising: a second template having athird surface that substantially conforms with at least a portion of afirst or second joint surface, the second template including at leastone guide for guiding a surgical instrument; and an attachment mechanismfor attaching the second template to at least one of the first templateand the at least one other template.
 34. The kit according to claim 30,wherein the joint is one of a knee joint, a hip joint, a shoulder joint,an elbow joint, a wrist joint, a finger joint, a toe joint, and an anklejoint.
 35. The kit according to claim 30, wherein at least a portion ofthe first surface substantially conforms to at least one of uncutsubchondral bone, uncut cartilage, and uncut bone.
 36. A method ofpartial or total knee replacement or resurfacing, the method comprising:positioning a first surface of a first instrument onto at least aportion of the tibial plateau, the first surface being substantially anegative of at least a portion of the tibial plateau; cross-referencinga second instrument to the first instrument to align position of thesecond instrument on the tibia, the second instrument including at leastone surgical cut guide; and directing a cut using the at least onesurgical guide of the second of the second instrument.
 37. The method ofclaim 36, wherein the cut is a tibial cut.
 38. The method of claim 36,wherein the first instrument is a template.
 39. The method of claim 36,wherein the second instrument is a template.
 40. The method of claim 36,wherein the second instrument is a surgical tool.
 41. The methodaccording to claim 36, wherein the first instrument includes a guide formaking a cut, the method further comprising directing a surgical cutusing the guide.
 42. The method of claim 41, wherein guide is a verticalguide and the cut is a tibial cut.
 43. The method of claim 41, whereinguide is a horizontal guide and the cut is a tibial cut.
 44. The methodaccording to claim 36, wherein the first instrument includes a medialedge that corresponds to a predetermined location for a vertical tibialcut, the method further comprising confirming the proper location of thevertical tibial cut based on the medial edge.
 45. The method accordingto claim 36, wherein at least a portion of the first surfacesubstantially conforms to at least one of uncut subchondral bone, uncutcartilage, and uncut bone.
 46. The method according to claim 36, whereinthe first surface of the instrument is based, at least in part, onelectronic image data of the tibial plateau.
 47. The method according toclaim 36, wherein cross-referencing includes attaching the firstinstrument to the second instrument.
 48. The method according to claim36, wherein the at least one guide of the second instrument guides asurgical instrument in making a cut on the tibia having a desired sloperelative to at least one of a biomechanical and an anatomical axis. 49.A method for testing at least one of ligament balancing and ligamenttension of a joint, the method comprising: inserting a first templatehaving a first surface onto a first joint surface, the first surfacesubstantially conforming to the first joint surface; and inserting asecond template onto the first joint surface, the second template havinga first surface that conforms with, and is substantially a negative of,the first joint surface, the second template having a thickness thatvaries from the first template.
 50. The method according to claim 49,further comprising selecting one of the first and second templates basedon at least one of ligament balancing and ligament tension.
 51. Themethod according to claim 50, further comprising: attaching a thirdtemplate to the selected template, the third template, including atleast one guide for guiding a surgical instrument; positioning the firstsurface of the selected template onto the first joint surface; andguiding the surgical instrument using the at least one guide.
 52. Themethod according to claim 49, wherein the joint is one of a knee joint,a hip joint, a shoulder joint, an elbow joint, a wrist joint, a fingerjoint, a toe joint, and an ankle joint.
 53. A system for articularrepair, the system comprising: a first template having a first surfaceand a second surface, the first surface substantially conforming with,and substantially a negative of, at least a portion of a distal femur; asecond template having a third surface that conforms with, and issubstantially a negative of, a portion of the distal femur, the secondtemplate including at least one guide for guiding a surgical instrumentin making a cut on the distal femur; and an attachment mechanism forattaching the second template to the first template.
 54. The systemaccording to claim 53, wherein the first or second template includes aguide for making a vertical femoral cut.
 55. The system according toclaim 53, wherein the second surface is at least one of substantiallyflat, substantially concave, substantially convex, and matched to one ofthe tibia and the femur.
 56. The system according to claim 53, furthercomprising at least one other template having a first surface and asecond surface, the first surface of the at least one other templateconforming with, and substantially a negative of, the at least a portionof the distal femur, each of the other templates capable of attaching tothe second template, wherein the first template and each of the othertemplates vary in thickness.
 57. The system according to claim 53,wherein at least a portion of the first surface substantially conformsto at least one of uncut subchondral bone, uncut cartilage, and uncutbone of a distal femur.
 58. The system according to claim 53, wherein atleast a portion of the second surface substantially conforms to at leastone of uncut subchondral bone, uncut cartilage, and uncut bone of adistal femur.
 59. The system according to claim 53, wherein at least aportion of the third surface substantially conforms to at least one ofuncut subchondral bone, uncut cartilage, and uncut bone of a tibia. 60.The system according to claim 53, wherein the attachment mechanismincludes at least one of a snapfit, dovetail and a cross-pin.
 61. Thesystem according to claim 53, wherein the attachment mechanism allowsfor rotation relative to one of an anatomical and a biomechanical axis.62. A system for articular repair, the system comprising: a firsttemplate having a first surface and a second surface, the first surfacesubstantially conforming to at least a portion of the distal femur, thefirst template including a medial edge that corresponds to apredetermined location for a vertical femoral or tibial cut.
 63. Thesystem according to claim 62, further comprising a second templatehaving a third surface substantially conforming to at least a portion ofthe distal femur or tibial plateau, the second template including atleast one guide for guiding a surgical instrument; and an attachmentmechanism for attaching the second template to the first template. 64.The system according to claim 62, wherein the first template includes aguide for guiding a surgical instrument.
 65. The system according toclaim 62, wherein the medial edge is adapted as a guide for making avertical tibial or femoral cut.
 66. The system according to claim 62,further comprising at least one other template having a first surfaceand a second surface, the first surface of the at least one othertemplate substantially conforming to at least a portion of the tibialplateau, wherein the first template and each of the other templates varyin thickness.
 67. The system according to claim 62, wherein at least aportion of the first surface substantially conforms to at least one ofuncut subchondral bone, uncut cartilage, and uncut bone.